Profile: Armm, Inc. offers high quality disposable medical devices and contract services. Our production, manufacturing, and assembly processes are done in certified clean room environments. We manufacture medical devices in accordance with EN 46002:1996 and ISO 13488:1996. We produce sterile wound drains, suction irrigation sets and suction and irrigation/infiltration tubing sets. Our disposable medical devices include MedDrain™ thoracic and mediastinal silicone catheters and closed wound drains; SuperFlow™ insufflation, tubing sets and products; and EndoSI™ suction / irrigation probes and wye tubing sets.

The company was founded in 1992, has revenues of USD 5-10 Million, has ~60 employees and is ISO, CE certified.

FDA Registration Number: 2028523

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• Abdominal Suction Tube

• Aspirator Filter

• Bronchoscopic Suction Tubes

• Cardiac Suction Tubes

• 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.

• Cone Suction Tubes

• Connecting Flexible Aspirating Tube (FDA Code: BYY / 880.6740) A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).

• Continuous Irrigation Catheter (FDA Code: GBQ / 878.4200)

• Contract Assembly

• Directional Suction Irrigator

• Ferguson-Frazier Suction Tubes

• Gas Filter

• Gas Filtering Tubes

• General & Plastic Surgery Laparoscope (FDA Code: GCJ / 876.1500) An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• General Surgical Manual Instrument (FDA Code: MDM / 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.

• Graft Suction Tubes

• Intracardiac Suction Tubes

• Irrigation Catheter (FDA Code: GBX / 878.4200)

• Laparoscopic Insufflator (FDA Code: HIF / 884.1730) A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.

• Laparoscopic Irrigator/Aspirator Suction Probe

• Mono and Double Lumen Sump Drains

• Multiple Lumen Catheter (FDA Code: GBP / 878.4200)

• Nasogastric Suction Tubes

• Pericardium Drainage Catheter

• Pituita Suction Tube for Infant

• Plastic Tubing

• Plastic Tubing Clamp

• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases.

• Replacement Suction Tubes

• Silicone Mediastinal Catheter

• Silicone Penrose Drainage Tube

• Silicone T-Y Drainage Tube

• Silicone Tubing

• Silicone Tubing, Medical Grade

• Silicone Y-Drainage Tube

• Sinus Endoscopy, Baron Suction Tube

• Sinus Endoscopy, Bipolar Suction Tube

• Standard Suction Tubes

• Straight Silicone Thoracic Catheter

• Suction Irrigator

• Suction Tube Attachment Device

• Suction Tube with Finger Valve

• Suction Tube, angular

• Suction Tubes

• Sump Drain

• Sump Suction Tubes

• Suprapubic Tube Drainage (FDA Code: FFA / 876.5090) A suprapubic urological catheter and accessories is a flexible tubular device that is inserted through the abdominal wall into the urinary bladder with the aid of a trocar and cannula. The device is used to pass fluids to and from the urinary tract. This generic type of device includes the suprapubic catheter and tube, Malecot catheter, catheter punch instrument, suprapubic drainage tube, and the suprapubic cannula and trocar.

• Surgical Suction Tubes

• Surgical Trays (FDA Code: LRP / 878.4800)

• Surgical Trays (FDA Code: LRP / 878.4800)