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The Hygia Health Services Reprocessed Blood Pressure Cuff is intended to be used in conjunction with non-invasive blood pressure monitoring systems by personnel properly trained in the use of manual or automatic sphygmomanometers as appropriate. The device is non-sterile and is intended as a single patient use device. It is available in neonatal through large adult size. The Hygia Health Services Reprocessed Blood Pressure Cuff is an accessory used by trained personnel in conjunction with non-invasive blood pressure measurement systems, primarily in a clinical setting.

Per CFR 870.1120, a Blood Pressure Cuff is a device that has an inflatable bladder within, or integral to, an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with an appropriate measuring device to determine a subject's blood pressure. The Hygia Health Services Reprocessed Blood Pressure Cuff comprises tubing attached to a soft inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb and secured by hook and loop closure. The device tubing is connected to an appropriate non-invasive blood pressure measurement system. The blood pressure cuffs contain no latex. Sizes include neonatal through large adult. Each cuff is packed in a sealed polyethylene (non-sterile) bag and each cuff is marked with the effective size range of limbs on which it may be used.