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
• Manual Tonometer (FDA Code: HKY / 886.1930) A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma. |
• Manual Trephines & Accessories (FDA Code: HBG / 882.4300) Manual cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments that are used without a power source on a patient's skull. |
• Manual/Powered Portable Aspiration Pump (FDA Code: BTA / 878.4780) A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. |
• Mastoid Chisel (FDA Code: JYD / 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. |
• Mastoid Searcher (FDA Code: JZC / 874.4420) |
• Measuring Ear Rod (FDA Code: JYZ / 874.4420) |
• Measuring Exerciser (FDA Code: ISD / 890.5360) Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation. |
• Measuring Gauge (FDA Code: JYJ / 874.4420) |
• Mechanical Noninvasive Ventilators |
• Mechanical Ventilation Circuits |
• Mechanical Ventilators |
• Medical Absorbent Fiber (FDA Code: FRL / 880.5300) A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category. |
• Medical Devices, Disinfectant (FDA Code: LRJ / 880.6890) A general purpose disinfectant is a germicide intended to process noncritical medical devices and equipment surfaces. A general purpose disinfectant can be used to preclean or decontaminate critical or semicritical medical devices prior to terminal sterilization or high level disinfection. Noncritical medical devices make only topical contact with intact skin. |
• Medical Probes (FDA Code: HXB / 888.4540) An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, burr, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench. |
• Medical Rasps (FDA Code: HTR / 878.4800) |
• Mercury Sphygmomanometer |
• Metabolism Analyzer |
• Metal Ureteral Basket Stone Dislodger (FDA Code: FFL / 876.4680) A ureteral stone dislodger is a device that consists of a bougie or a catheter with an expandable wire basket near the tip, a special flexible tip, or other special construction. It is inserted through a cystoscope and used to entrap and remove stones from the ureter. This generic type of device includes the metal basket and the flexible ureteral stone dislodger. |
• Metal Vaginal Speculum (FDA Code: HDF / 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: |
• Metal/Plastic Urethral Sound (FDA Code: FBX / 876.5520) A urethral dilator is a device that consists of a slender hollow or solid instrument made of metal, plastic, or other suitable material in a cylindrical form and in a range of sizes and flexibilities. The device may include a mechanism to expand the portion of the device in the urethra and indicate the degree of expansion on a dial. It is used to dilate the urethra. This generic type of device includes the mechanical urethral dilator, urological bougies, metal or plastic urethral sound, urethrometer, filiform, and filiform follower. |
• Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. |
• Methyl Methacrylate for Cranioplasty Barium Sulfate Accessory (FDA Code: MYU / 882.5300) |
• Microsurgical Ear Hook (FDA Code: JYL / 874.4420) |
• Microsurgical Ear Pick (FDA Code: JYT / 874.4420) |
• Microsurgical Instruments (FDA Code: GZX / 882.4525) A microsurgical instrument is a nonpowered surgical instrument used in neurological microsurgery procedures. |
• Middle Ear Chisel (FDA Code: JYE / 874.4420) |
• Monitoring Spirometer (FDA Code: BZK / 868.1850) A monitoring spirometer is a device used to measure continuously a patient's tidal volume (volume of gas inhaled by the patient during each respiration cycle) or minute volume (the tidal volume multiplied by the rate of respiration for 1 minute) for the evaluation of the patient's ventilatory status. |
• Mouth Gags (FDA Code: KBN / 874.4420) |
• Multichannel Hematology Analyzers |
• Nail Extractors (FDA Code: HWB / 888.4540) |
• Nasal Chisel (FDA Code: KAN / 878.4800) |
• Nasal Curette (FDA Code: KAP / 874.4420) |
• Nasal Inhaler (FDA Code: KCO / 874.5220) An ear, nose, and throat drug administration device is one of a group of ear, nose, and throat devices intended specifically to administer medicinal substances to treat ear, nose, and throat disorders. These instruments include the powder blower, dropper, ear wick, manual nebulizer pump, and nasal inhaler. |
• Nasal Knife (FDA Code: KAS / 874.4420) |
• Nasal Punch (FDA Code: KAY / 874.4420) |
• Nasal Rasps (FDA Code: KBA / 874.4420) |
• Nasal Rongeur (FDA Code: KBB / 874.4420) |
• Nasal Saw (FDA Code: KBC / 874.4420) |
• Nasal Scissors (FDA Code: KBD / 874.4420) |
• Nasal Scissors Straight (FDA Code: KBD / 874.4420) |
• Nasal Snare (FDA Code: KBE / 874.4420) |
• Nasal Splints (FDA Code: EPP / 874.5800) An external nasal splint is a rigid or partially rigid device intended for use externally for immobilization of parts of the nose. |
• Nasopharyngeal Airways (FDA Code: BTQ / 868.5100) A nasopharyngeal airway is a device used to aid breathing by means of a tube inserted into a patient's pharynx through the nose to provide a patent airway. |
• Nasopharyngeal Electrodes (FDA Code: GZK / 882.1340) A nasopharyngeal electrode is an electrode which is temporarily placed in the nasopharyngeal region for the purpose of recording electrical activity. |
• Needle Electrode (FDA Code: GXZ / 882.1350) A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals. |
• Neonatal Adult Oxygen Sensor |
• Nerve Conduction Velocity Measurement Device (FDA Code: JXE / 882.1550) A nerve conduction velocity measurement device is a device which measures nerve conduction time by applying a stimulus, usually to a patient's peripheral nerve. This device includes the stimulator and the electronic processing equipment for measuring and displaying the nerve conduction time. |
• Neurological Tray (FDA Code: OJG / 882.4525) |
• Neurology Self-Retaining Retractor (FDA Code: GZT / 882.4800) A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery. |
• Neurosurgical Head Holder (FDA Code: HBL / 882.4460) A neurosurgical head holder (skull clamp) is a device used to clamp the patient's skull to hold head and neck in a particular position during surgical procedures. |