Byron Medical, Inc.

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Web: http://www.byrondirect.com
E-Mail:
Address: 602 W. Rillito, Tucson, Arizona 85705, USA
Phone: +1-(520)-573-0857, 800-777-3434 | Fax: +1-(520)-746-1757 | Map/Directions >>
 
 

Profile: Byron Medical, Inc. introduced ActiPatch™, which is a new innovation in micro electrical therapy. Our alpha infusion pumps comes in two sizes, the 200ml and the 450 ml, thus offering the physician versatility when deciding upon medication amounts & duration times. Our ARC-HII™ eliminates lateral & vibratory movement at the cannula tip which allows the instrument to maintain easily the intended plane of entry.

The company was founded in 2002, has revenues of USD 10-25 Million, has ~60 employees and is ISO 9001, CE certified. NASDAQ:MNTR (SEC Filings)

FDA Registration Number: 2025576

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• Adhesive Elastic Bandage Tape
• Adhesive Elastic Stretch Tape
• Adult-Pediatric Volumetric Infusion Pumps
• Aesthetic Dermal Implant (FDA Code: LMH)
• Ambulatory Infusion Pumps
• Anesthesia Infusion Pump Tubing
• Anesthetic Infusion Pump (FDA Code: FRN / 880.5725)
An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.
• Antibiotic Medicated Bandages
• Batteries & Battery Assemblies for Infusion Pumps
• Body Contouring Systems
• Breast Implant Volume Mammary Sizer (FDA Code: MRD)
• Caromedr Post Surgery Garments
• Catheter Accessories (FDA Code: KGZ / 878.4200)
An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions. Examples include irrigation and drainage catheters, pediatric catheters, peritoneal catheters (including dialysis), and other general surgical catheters. An introduction/drainage catheter accessory is intended to aid in the manipulation of or insertion of the device into the body. Examples of accessories include adaptors, connectors, and catheter needles.
• Clean Room Garments
• Constant-flow Infusion Pump
• Cosmetic Pharmaceuticals, Gel Sheeting
• Cosmetic Surgery, Protective Eyewear
• Desmarres Lid Retractors
• Disposable Irrigating Syringe
• Dual-Channel Volumetric Infusion Pump
• Elastic Binder (FDA Code: KMO / 880.5160)
A therapeutic medical binder is a device, usually made of cloth, that is intended for medical purposes and that can be secured by ties so that it supports the underlying part of the body or holds a dressing in place. This generic type of device includes the abdominal binder, breast binder, and perineal binder.
• Examination Gown (FDA Code: FME / 880.6265)
An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination.
• Garments
• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)
A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.
• General Diagnostic Equipment
• General Medical Supplies
• General Surgery Supplies
• General Surgical Aids
• General Surgical Instruments
• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)
• Goggles & Protective Eyewear
• Incontinence Garments
• Inflatable Skin Expander (FDA Code: LCJ)
• Infusion Pump Analysis System
• Infusion Pump Repair
• Infusion Pump Service Parts
• Infusion Pump Stands
• Infusion Pump Tester
• Infusion Pumps, Ambulatory Pumps
• Insulin Disposable Syringes Kits
• Internal Inflatable Breast Prosthesis (FDA Code: FWM / 878.3530)
A silicone inflatable breast prosthesis is a silicone rubber shell made of polysiloxane(s), such as polydimethylsiloxane and polydiphenylsiloxane, that is inflated to the desired size with sterile isotonic saline before or after implantation. The device is intended to be implanted to augment or reconstruct the female breast.
• Internal Non-Inflatable Breast Prosthesis (FDA Code: FTR / 878.3540)
• IV Catheters & Infusion Sets
• IV Medication Delivery Systems, volumetric infusion pumps
• IV Stand Accessories, Multi-Infusion Pump
• Jaeger Lid Plates
• Latex Free Cotton Adhesive Elastic Tape
• Lipoplasty Suction System (FDA Code: MUU / 878.5040)
A suction lipoplasty system is a device intended for aesthetic body contouring. The device consists of a powered suction pump (containing a microbial filter on the exhaust and a microbial in-line filter in the connecting tubing between the collection bottle and the safety trap), collection bottle, cannula, and connecting tube. The microbial filters, tubing, collection bottle, and cannula must be capable of being changed between patients. The powered suction pump has a motor with a minimum of 1/3 horsepower, a variable vacuum range from 0 to 29.9 inches of mercury, vacuum control valves to regulate the vacuum with accompanying vacuum gauges, a single or double rotary vane (with or without oil), a single or double diaphragm, a single or double piston, and a safety trap.
• Liposuction Aspirator
• Lymphedema Compression Garments

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