Emesis Basin Suppliers
Limit companies to: Worldwide USA
Plastics Development Inc | Address: 720 Northern Rd., Mount Juliet, Tennessee 37122, USA 
Phone: +1-(865)-938-7828
Products: Surgical Trays (FDA Code: LRP), Surgical Trays (FDA Code: LRP), Bedpan (FDA Code: FOB), Emesis Basin (FDA Code: FNY), Graduated Liquid Medication Container (FDA Code: KYW), ...
Plastics Development Inc manufactures sanitary food containers. We also manufacture storage chests, cabinets, liquid containers, storage bags and surgical trays. more...
Phone: +1-(865)-938-7828
Products: Surgical Trays (FDA Code: LRP), Surgical Trays (FDA Code: LRP), Bedpan (FDA Code: FOB), Emesis Basin (FDA Code: FNY), Graduated Liquid Medication Container (FDA Code: KYW), ...
Plastics Development Inc manufactures sanitary food containers. We also manufacture storage chests, cabinets, liquid containers, storage bags and surgical trays. more...
Kentron Health Care, Inc. | Address: 3604 Kelton Jackson Rd., Springfield, Tennessee 37172, USA
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Oxygen Masks (FDA Code: BYG), Stethoscopes, Splints, Forceps (FDA Code: HTD), Finger Splints, Esophageal Stethoscopes (FDA Code: BZW), ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
www.kentronmedical.com | Send Inquiry | Phone: +1-(866)-385-0573
FDA Registration: 1062671
Products: Oxygen Masks (FDA Code: BYG), Stethoscopes, Splints, Forceps (FDA Code: HTD), Finger Splints, Esophageal Stethoscopes (FDA Code: BZW), ...
Kentron Health Care, Inc. is a manufacturer of surgical and medical instruments. Our product line includes sterile and non sterile latex gloves, vinyl & polyethylene gloves, hospital plastics, nursing more...
Argon Medical Devices Inc. | Address: 1445 Flat Creek Road, Athens, Texas 75751, USA
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Electronic Stethoscopes (FDA Code: DQD), Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
www.argonmedical.com | Send Inquiry | Phone: +1-(903)-675-9321, 800-927-4669
FDA Registration: 1625425
Products: Catheter Introducers (FDA Code: DYB), Catheter Introducers, Mullins Design, Electronic Stethoscopes (FDA Code: DQD), Irrigation Sets & Tubing, General Medical Supplies, General Surgical Instruments, ...
Argon Medical Devices Inc. manufactures and supplies single-use vascular access devices. Our products are divided into cardiology, radiology and critical care product lines. Our products include arter more...
Care Products Inc | Address: PO Box 720193, Mc Allen, Texas 78504, USA
www.careproductsinc.com | Send Inquiry | Phone: +1-(800)-445-7345
FDA Registration: 3004839392 Year Established: 1987
Products: Specialty Shower Chair Commodes, Patient Transfer Chair, Geriatric Chairs (FDA Code: FRJ), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Emesis Basin (FDA Code: FNY), Wheeled (Mobile) Stretcher (FDA Code: FPO), ...
Care Products, Inc. manufactures PVC medical equipment for the long term care market. Our product list comprises of geriatric chairs, low beds, casters, walkers, shower chairs, linen carts and gurneys more...
www.careproductsinc.com | Send Inquiry | Phone: +1-(800)-445-7345
FDA Registration: 3004839392 Year Established: 1987
Products: Specialty Shower Chair Commodes, Patient Transfer Chair, Geriatric Chairs (FDA Code: FRJ), Cardiopulmonary Resuscitation Emergency Cart (FDA Code: BZN), Emesis Basin (FDA Code: FNY), Wheeled (Mobile) Stretcher (FDA Code: FPO), ...
Care Products, Inc. manufactures PVC medical equipment for the long term care market. Our product list comprises of geriatric chairs, low beds, casters, walkers, shower chairs, linen carts and gurneys more...
Medical Techniques USA | Address: 125 North 400 West, Suite C, North Salt Lake, Utah 84054, USA
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Guidewires, Catheter Introducers (FDA Code: DYB), Gowns, Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Disposable Procedure Kit, ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
www.medicaltechniquesusa.com | Send Inquiry | Phone: +1-(801)-936-4501
FDA Registration: 1721368 Year Established: 1980 Annual Revenues: USD 1-5 Million Quality: ISO 13485, CE Certified
Products: Guidewires, Catheter Introducers (FDA Code: DYB), Gowns, Surgical Drapes & Packs (FDA Code: KKX), Surgical Drapes (FDA Code: KKX), Disposable Procedure Kit, ...
Medical Techniques USA provides cardiology, radiology, angiography, and surgical products. Our products are designed to diagnostic and interventional catheterization needs. We manufacture disposable p more...
Polar Ware Company | Address: 502 Highway 67, Kiel, Wisconsin 53083-3943, USA
www.polarware.com | Send Inquiry | Phone: +1-(920)-894.2490, 800.237.3655
FDA Registration: 2183714 Year Established: 1907 Annual Revenues: USD 1-5 Million Employee Count: ~250
Products: Instrument Stands, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Plasticware, Trays, ...
Polar Ware Company offers surgical products. Our patient care products include a complete line of reusable stainless steel patient products. We also deal with a wide selection of color identifiable pl more...
www.polarware.com | Send Inquiry | Phone: +1-(920)-894.2490, 800.237.3655
FDA Registration: 2183714 Year Established: 1907 Annual Revenues: USD 1-5 Million Employee Count: ~250
Products: Instrument Stands, General Medical Supplies, General Surgical Instruments, General Surgery Supplies, Plasticware, Trays, ...
Polar Ware Company offers surgical products. Our patient care products include a complete line of reusable stainless steel patient products. We also deal with a wide selection of color identifiable pl more...
Siam Intermagnate Co., Ltd. | Address: 138 Romklao Rd, Klongsampraved, Ladkrabang, Bangkok 10520, Thailand
www.siamintm.com | Send Inquiry | Phone: +2-(360)-8710,8711,8801
FDA Registration: 3003701178 Year Established: 1996 Quality: ISO 9001 , ISO 13485, CE Mark Certified
Products: Urinals (FDA Code: FNP), Surgical Instrument Tray (FDA Code: FSM), Bedpan (FDA Code: FOB), Emesis Basin (FDA Code: FNY), Graduated Liquid Medication Container (FDA Code: KYW), Embedding Container (FDA Code: KER), ...
Siam Intermagnate Co., Ltd. manufactures deep drawn stainless steel products serving medical and healthcare professionals. Our stainless steel hospital holloware includes bedpan, urinal, fracture bedp more...
www.siamintm.com | Send Inquiry | Phone: +2-(360)-8710,8711,8801
FDA Registration: 3003701178 Year Established: 1996 Quality: ISO 9001 , ISO 13485, CE Mark Certified
Products: Urinals (FDA Code: FNP), Surgical Instrument Tray (FDA Code: FSM), Bedpan (FDA Code: FOB), Emesis Basin (FDA Code: FNY), Graduated Liquid Medication Container (FDA Code: KYW), Embedding Container (FDA Code: KER), ...
Siam Intermagnate Co., Ltd. manufactures deep drawn stainless steel products serving medical and healthcare professionals. Our stainless steel hospital holloware includes bedpan, urinal, fracture bedp more...
Allegiance Healthcare (thailand) Limited | Address: 7/111 Moo 4 Highway# 331, Mabyangporn, Pluakdaeng, Rayong 21140, Thailand
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Send Inquiry | Phone: +66-(38)-956-155-62
FDA Registration: 9615914
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Arthroscopes (FDA Code: HRX), Surgical Drapes & Packs (FDA Code: KKX), Catheter Accessories (FDA Code: KGZ), ...
Allegiance Healthcare (Thailand) Limited, is a manufacturer of surgical and medical gloves. more...
Super Master Developing Co., Ltd. | Address: Rm4-2, F14, No. 59, Sec. 2, Tun Hwa South Rd., Taipei, Taiwan, Taiwan 
Phone: +886-(2)-27083066
FDA Registration: 3005286128
Products: Disposable Surgical Instrument (FDA Code: KDC), Disposable Medical Scissors (FDA Code: JOK), Emesis Basin (FDA Code: FNY), Circumcision Bell (FDA Code: FHG), ...
Super Master Developing Co., Ltd. is a provider of disposable surgical instruments. more...
Phone: +886-(2)-27083066
FDA Registration: 3005286128
Products: Disposable Surgical Instrument (FDA Code: KDC), Disposable Medical Scissors (FDA Code: JOK), Emesis Basin (FDA Code: FNY), Circumcision Bell (FDA Code: FHG), ...
Super Master Developing Co., Ltd. is a provider of disposable surgical instruments. more...
Sur - Med | Address: 45-C, Aslam Arcade, Street No. 11, Badar Commercial Area, Phase-, D. H. A., Karachi 75500, Pakistan
www.sur-med-intl.com | Send Inquiry | Phone: +92-(52)-429-0671
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Sur-Med manufactures surgical and medical instruments. Our products include orthopedic implants, and instruments, anesthesia products, laryngoscopes sets, diagnostic equipments and products, general s more...
www.sur-med-intl.com | Send Inquiry | Phone: +92-(52)-429-0671
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Sur-Med manufactures surgical and medical instruments. Our products include orthopedic implants, and instruments, anesthesia products, laryngoscopes sets, diagnostic equipments and products, general s more...
House Of Surgical (Pvt) Ltd. | Address: P.o. Box 105, Sialkot 51310, Pakistan
www.hos-group.com | Send Inquiry | Phone: +92-(52)-6526900
Year Established: 1953 Quality: ISO 13485: 2003, CE Certified
Products: Pelvimeters, Laryngoscopes, Scalpels, Dressing Forceps, Nasal Specula, Obstetrical Forceps (FDA Code: HDA), ...
House Of Surgical (Pvt) Ltd. manufactures and exports surgical instruments. Our product list comprises of artery forceps, needle holders, scissors, suction tubes, scalpels, and sponge & dressing force more...
www.hos-group.com | Send Inquiry | Phone: +92-(52)-6526900
Year Established: 1953 Quality: ISO 13485: 2003, CE Certified
Products: Pelvimeters, Laryngoscopes, Scalpels, Dressing Forceps, Nasal Specula, Obstetrical Forceps (FDA Code: HDA), ...
House Of Surgical (Pvt) Ltd. manufactures and exports surgical instruments. Our product list comprises of artery forceps, needle holders, scissors, suction tubes, scalpels, and sponge & dressing force more...
Mian Shahid Corp. | Address: St #1 Chowk Shahab Pura, Muzaffar Pur, Sialkot, PK-PB, Pakistan
www.mianshahid.com | Send Inquiry | Phone: +92-(523)-562-641
FDA Registration: 3002834291
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Mian Shahid Corp. is a manufacturer and supplier of dental and surgical instruments. Our surgical products include intestinal clamps, artery forceps, retractros, kidney clamps and forceps, mallets & n more...
www.mianshahid.com | Send Inquiry | Phone: +92-(523)-562-641
FDA Registration: 3002834291
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Mian Shahid Corp. is a manufacturer and supplier of dental and surgical instruments. Our surgical products include intestinal clamps, artery forceps, retractros, kidney clamps and forceps, mallets & n more...
Dodhy Brothers | Address: Al-Hadi Town Defence Rd., Sialkot, Punjab 51310, Pakistan
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Dodhy Brothers deals with basins, chisels, canes, crown removers, curretes, cutters and forceps. We supply pliers, probes, retractors, knives, mouth gags and scissors. more...
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Bone Hooks (FDA Code: KIK), Bone Rasps (FDA Code: HTR), Surgical Retractor Systems (FDA Code: GAD), Human Bone Rasps (FDA Code: HTR), ...
Dodhy Brothers deals with basins, chisels, canes, crown removers, curretes, cutters and forceps. We supply pliers, probes, retractors, knives, mouth gags and scissors. more...
The Mughal Surgical (Pvt) Ltd | Address: C-95 Industrial Estate, P.O.Box 274, Punjab Province, Sialkot, Punjab 51340, Pakistan
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
www.mughalsurgical.com | Send Inquiry | Phone: +92-(52)-355-3671
Quality: ISO 9001:2008, ISO 13485:2003, CE Certified
Products: Forceps (FDA Code: HTD), Gastroenterologic Needle Holder (FDA Code: FHQ), Bone Rasps (FDA Code: HTR), Wire Twisters (FDA Code: HXS), Elastic Bandages (FDA Code: FQM), Surgical Retractor Systems (FDA Code: GAD), ...
The Mughal Surgical (Pvt)Ltd provides instruments to surgical, dental, veterinary and beauty care fields. Our surgical products include scalpels, scissors, dressing & tissue forceps, retractors, needl more...
Tinopal Surgical Corporation Pvt Ltd. | Address: Unit No. 1, 55/57-B., Small Industries Estate, Sialkot, Punjab 51311, Pakistan
www.tinopal.com | Send Inquiry | Phone: +92-(52)-3255354, 3255454
FDA Registration: 9611070 Year Established: 1973 Quality: ISO 9001:2000, QSR/cGMP, and CE Mark Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Tinopal Surgical Corporation Pvt Ltd. specializes in offering surgical instruments. We offer surgical, dental and single use surgical instruments. Our surgical instruments include diagnostic instrumen more...
www.tinopal.com | Send Inquiry | Phone: +92-(52)-3255354, 3255454
FDA Registration: 9611070 Year Established: 1973 Quality: ISO 9001:2000, QSR/cGMP, and CE Mark Certified
Products: Vaginal Retractors (FDA Code: HDL), Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), ...
Tinopal Surgical Corporation Pvt Ltd. specializes in offering surgical instruments. We offer surgical, dental and single use surgical instruments. Our surgical instruments include diagnostic instrumen more...
Plasti Lab S.A.R.L. | Address: Roumieh Main Road, El Khoury Bldg., Roumieh, El Mein 70407, Lebanon
www.plastilab-lb.com | Send Inquiry | Phone: +961-(1)-902-000
Products: Umbilical Cord Clamps, Tongue Depressors (FDA Code: FMA), Medicine Cups, Tissue Cassette (FDA Code: IDZ), Micro Pipette (FDA Code: JRC), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), ...
Plasti Lab manufactures laboratory, medical and dental products. Our laboratory products include petri dishes, blood collection tubes, test tubes, sharps containers, micro pipette tips, specimen conta more...
www.plastilab-lb.com | Send Inquiry | Phone: +961-(1)-902-000
Products: Umbilical Cord Clamps, Tongue Depressors (FDA Code: FMA), Medicine Cups, Tissue Cassette (FDA Code: IDZ), Micro Pipette (FDA Code: JRC), Nonresorbable Gauze/sponge for External Use (FDA Code: NAB), ...
Plasti Lab manufactures laboratory, medical and dental products. Our laboratory products include petri dishes, blood collection tubes, test tubes, sharps containers, micro pipette tips, specimen conta more...
C.B.M. S.R.L. | Address: 26038 Torre De ' Picenardi(Cremona), Via Castello 10/A 26038, Italy
www.cbm-srl.com | Send Inquiry | Phone: +39-(0375)-394095
FDA Registration: 9680909 Year Established: 1962 Quality: UNI EN ISO 9001:2000, UNI EN ISO 13485:2004 Certified
Products: Surgical Trays (FDA Code: LRP), Urinals (FDA Code: FNP), Ophthalmic Instrument Stand (FDA Code: HMG), Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Infusion Stand (FDA Code: FOX), Surgical Instrument Tray (FDA Code: FSM), ...
C.B.M.S.R.L, manufactures and distributes medical equipment, especially in the area of sterilisation and manufacturing equipment. The articles produced have always been used in hospitals, dental and a more...
www.cbm-srl.com | Send Inquiry | Phone: +39-(0375)-394095
FDA Registration: 9680909 Year Established: 1962 Quality: UNI EN ISO 9001:2000, UNI EN ISO 13485:2004 Certified
Products: Surgical Trays (FDA Code: LRP), Urinals (FDA Code: FNP), Ophthalmic Instrument Stand (FDA Code: HMG), Non-Powered Ophthalmic Instrument Stand (FDA Code: HMG), Infusion Stand (FDA Code: FOX), Surgical Instrument Tray (FDA Code: FSM), ...
C.B.M.S.R.L, manufactures and distributes medical equipment, especially in the area of sterilisation and manufacturing equipment. The articles produced have always been used in hospitals, dental and a more...
Northstar Healthcare Holdings Limited | Address: 30 Herbert Street, Dublin 2, Ireland
Phone: +353-(815)-322-4038
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Suture Removal Kit (FDA Code: MCZ), Patient Examination Gowns and Capes (FDA Code: FME), Manual Beds (FDA Code: FNJ), Arm Slings (FDA Code: ILI), ...
Northstar Healthcare Holdings Limited provides adhesive bandages, surgical dresses, wound dressing kits, elastic bandages and crutches. more...
Phone: +353-(815)-322-4038
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Suture Removal Kit (FDA Code: MCZ), Patient Examination Gowns and Capes (FDA Code: FME), Manual Beds (FDA Code: FNJ), Arm Slings (FDA Code: ILI), ...
Northstar Healthcare Holdings Limited provides adhesive bandages, surgical dresses, wound dressing kits, elastic bandages and crutches. more...
United Poly Engineering Pvt. Ltd. | Address: D- 13/3 Okhla Indutrial Area Phase-II, New Delhi, Delhi 110020, India 
www.unitedpoly.com | Send Inquiry | Phone: +91-(11)-26388564
FDA Registration: 9680168
Products: Surgical Trays (FDA Code: LRP), Trolleys, Bodies Transport, Stainless Steel Kidney Tray, Plastic Kidney Tray, Mobile Operation Theatre Lights, Ceiling Operation Theatre Lights, ...
United Poly Engg. Pvt. Ltd. produces stainless steel and aluminum hospital hollowares. Our product line includes kidney trays, surgical trays, galipot, instrument sterlizers, dressing drums, wash basi more...
www.unitedpoly.com | Send Inquiry | Phone: +91-(11)-26388564
FDA Registration: 9680168
Products: Surgical Trays (FDA Code: LRP), Trolleys, Bodies Transport, Stainless Steel Kidney Tray, Plastic Kidney Tray, Mobile Operation Theatre Lights, Ceiling Operation Theatre Lights, ...
United Poly Engg. Pvt. Ltd. produces stainless steel and aluminum hospital hollowares. Our product line includes kidney trays, surgical trays, galipot, instrument sterlizers, dressing drums, wash basi more...
Narang Medical Limited | Address: Narang Tower, 46 Community Centre, Naraina Ph-I, New Delhi, Delhi 110028, India
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
www.narang.com | Send Inquiry | Phone: +91-(11)-45554000, 25892020
FDA Registration: 9613910 Quality: ISO 9001:2000, ISO 13485:2003, CE and WHO Certified
Products: Medical Thermometers, Stethoscopes, Umbilical Cord Clamps, Vacuum Extractors, Autoclaves, Dry Heat Sterilizers (FDA Code: KMH), ...
Narang Medical Limited is a manufacturer & exporter of medical supplies, surgical instruments, hospital equipment, laboratory products, diagnostics and sundries. Our products include laryngoscope sets more...
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FDA Code / Regulation: FNY / 880.6730
A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. The device also is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
