Profile: Hygia Health Services, Inc. focuses on reprocess of non-critical and semi-critical medical devices. Our services include device recovery, staff compliance, reporting and device delivery.
FDA Registration Number: 1065594
13 Products/Services (Click for related suppliers)
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• Anesthetic Gas Mask (FDA Code: BSJ / 868.5550) An anesthetic gas mask is a device, usually made of conductive rubber, that is positioned over a patient's nose or mouth to direct anesthetic gases to the upper airway. |
• Compressible Limb Sleeve (FDA Code: JOW / 870.5800) A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb. |
• Electrode Cables (FDA Code: IKD / 890.1175) An electrode cable is a device composed of strands of insulated electrical conductors laid together around a central core and intended for medical purposes to connect an electrode from a patient to a diagnostic machine. |
• Endoscopic Bite Blocks (FDA Code: MNK / 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. |
• Medical Devices |
• Pelvic Support Band (FDA Code: ISR / 890.3025) A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint. |
• Pneumatic Tourniquet (FDA Code: KCY / 878.5910) A pneumatic tourniquet is an air-powered device consisting of a pressure-regulating unit, connecting tubing, and an inflatable cuff. The cuff is intended to be wrapped around a patient's limb and inflated to reduce or totally occlude circulation during surgery. |
• Pressure Infusor for I.V. Bags (FDA Code: KZD / 880.5420) A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid. |
• Reprocessed Blood Pressure Cuff (FDA Code: NPP / 870.1120) A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure. |
• Reprocessed Oximeter (FDA Code: NLF / 870.2700) An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter. |
• Reprocessed Tissue Saturation Oximeter (FDA Code: NMD / 870.2700) |
• Rigid Cervical-Thoracic Orthosis (FDA Code: IQF / 890.3490) A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints. |
• Tracheal Tube Stylet (FDA Code: BSR / 868.5790) A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient. |