Profile: Vyaire Medical, Inc. develops & distributes technology medical devices that are used in respiratory care, neurology, vascular medicine and critical care. Our Infant Flow® SiPAP™ renders bi-level nasal CPAP for the spontaneously breathing neonate through delivery of sighs above a baseline NCPAP pressure. Our Viasprint™ 150P consists of a dual mode handlebar adjustment.

The company was founded in 2001, has revenues of USD 50-100 Million, has ~230 employees and is ISO 9001, CE certified. NYSE:CAH (SEC Filings)

FDA Registration Number: 2050001

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• Gas Volume Calibrator (FDA Code: BXW / 868.1870) A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume.

• Gaseous Phase Carbon-Dioxide Gas Analyzer (FDA Code: CCK / 868.1400) A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.

• Gaseous Phase Carbon-Monoxide Gas Analyzer (FDA Code: CCJ / 868.1430) A carbon monoxide gas analyzer is a device intended to measure the concentration of carbon monoxide in a gas mixture to aid in determining the patient's ventilatory status. The device may use techniques such as infrared absorption or gas chromatography.

• Gaseous Phase Nitrogen Gas Analyzer (FDA Code: CCI / 868.1690) A nitrogen gas analyzer is a device intended to measure the concentration of nitrogen in respiratory gases to aid in determining a patient's ventilatory status. The device may use techniques such as gas chromatography or mass spectrometry.

• Gaseous Phase Nitrous-Oxide Gas Analyzer (FDA Code: CBR / 868.1700) A nitrous oxide gas analyzer is a device intended to measure the concentration of nitrous oxide anesthetic in a gas mixture. The device may use techniques such as infrared absorption or mass spectrometry.

• Gaseous Phase Oxygen Gas Analyzer (FDA Code: CCL / 868.1720) An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.

• Gastro-Urology Hook (FDA Code: FHB / 876.4730) A manual gastroenterology-urology surgical instrument and accessories is a device designed to be used for gastroenterological and urological surgical procedures. The device may be nonpowered, hand-held, or hand-manipulated. Manual gastroenterology-urology surgical instruments include the biopsy forceps cover, biopsy tray without biopsy instruments, line clamp, nonpowered rectal probe, nonelectrical clamp, colostomy spur-crushers, locking device for intestinal clamp, needle holder, gastro-urology hook, gastro-urology probe and director, nonself-retaining retractor, laparotomy rings, nonelectrical snare, rectal specula, bladder neck spreader, self-retaining retractor, and scoop.

• Gastro-Urology Needle (FDA Code: FHR / 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.

• Gastro-Urology Probe and Director (FDA Code: FGM / 876.4730)

• Gastro-Urology Stylet (FDA Code: EZB / 876.5130) A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudecatheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

• Gastro-Urology Trocar (FDA Code: FBQ / 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.

• Gastroenterologic Needle Holder (FDA Code: FHQ / 876.4730)

• General & Plastic Saw Surgical Blade (FDA Code: GFA / 878.4820) Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

• General & Plastic Surgery Forceps (FDA Code: GEN / 878.4800)

• 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 & Plastic Surgery Mirror (FDA Code: FTX / 878.4800)

• General & Plastic Surgery Surgical Cannula (FDA Code: GEA / 878.4800)

• General & Plastic Surgery Surgical Clamp (FDA Code: GDJ / 878.4800)

• General & Plastic Surgery Surgical Dissector (FDA Code: GDI / 878.4800)

• General & Plastic Surgery Surgical Elevator (FDA Code: GEG / 878.4800)

• General & Plastic Surgery Surgical Gouge (FDA Code: GDH / 878.4800)

• General & Plastic Surgery Surgical Hook (FDA Code: GDG / 878.4800)

• General & Plastic Surgery Surgical Mallet (FDA Code: GFJ / 878.4800)

• General & Plastic Surgery Surgical Rasp (FDA Code: GAC / 878.4800)

• General & Plastic Surgery Surgical Spatula (FDA Code: GAF / 878.4800)

• General Medical Supplies

• General Surgery Supplies

• General Surgery Tray (FDA Code: LRO / 878.4370) A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

• General Surgical Manual Instrument (FDA Code: MDM / 878.4800)

• General Surgical Scissors (FDA Code: LRW / 878.4800)

• General use Surgical Curettes (FDA Code: FZS / 878.4800)

• Graduated Liquid Medication Container (FDA Code: KYW / 880.6430) A Liquid medication dispenser is a device intended for medical purposes that is used to issue a measured amount of liquid medication.

• Guiding Probes

• Gynecologic Laparoscope and Accessories (FDA Code: HET / 884.1720) A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

• Gynecological Biopsy Forceps (FDA Code: HFB / 884.4530) An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:

• Gynecological Fibroid Hook (FDA Code: HDE / 884.4520) An obstetric-gynecologic general manual instrument is one of a group of devices used to perform simple obstetric and gynecologic manipulative functions. This generic type of device consists of the following:

• Gynecological Surgical Forceps (FDA Code: HCZ / 884.4530)

• Hand Splint and Component (FDA Code: ILH / 890.3475) A limb orthosis (brace) is a device intended for medical purposes that is worn on the upper or lower extremities to support, to correct, or to prevent deformities or to align body structures for functional improvement. Examples of limb orthoses include the following: A whole limb and joint brace, a hand splint, an elastic stocking, a knee cage, and a corrective shoe.

• Hand-Held Dopplers

• Hearing Aid / Earphone and Analysis Systems (FDA Code: ETW / 874.3310) A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

• Hearing Kit Accessories

• Heat and Moisture Condenser (FDA Code: BYD / 868.5375) A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.

• Helium Gas Analyzer (FDA Code: BSE / 868.1640) A helium gas analyzer is a device intended to measure the concentration of helium in a gas mixture during pulmonary function testing. The device may use techniques such as thermal conductivity, gas chromatography, or mass spectrometry.

• Hematology Analyzers

• Hemorrhoidal Ligator (FDA Code: FHN / 876.4400) A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.

• Hemostatic Clip Applier (FDA Code: HBT / 878.4800)

• Hemostatic Clip, Implant (FDA Code: MCH / 878.4300) An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

• Hemostats (FDA Code: HRQ / 878.4800)

• High-Frequency Ventilator (FDA Code: LSZ)

• Home Sleep Testing Kit