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NA - 989803150401

A band-like device that has an inflatable bladder in an inelastic sleeve with one or two connecting tubes with connector (typically locking connectors) that can be connected to a mechanism for inflating and deflating the bladder and/or a sphygmomanometer or a patient monitoring device/system that is used to determine a patient's blood pressure. It is wrapped around the upper arm or the leg (thigh) of the patient. This is a reusable device which may be intended for single-patient or multi-patient reuse.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OED

Device Name: Antimicrobial Blood Pressure Cuff

Device Class: 2

Physical State: The device is a typically a textile enfolded over an inflatable bladder.

Definition: Device is a replacement cuff to be used in conjunction with a non-invasive blood pressure monitor. Together the devices determine blood pressures and heart rate. This particular cuff contains an embedded antimicrobial. A blood pressure cuff is a device that has an inflatable bladder in an elastic sleeve(cuff) with a mechanism for inflating the bladder. The cuff is used to determine a subject's blood pressure.

Submission Type ID: 1

Review Panel: CV

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The blood pressure cuff wraps around the subject's arm or wrist and the bladder is inflated. The pressure from the bladder occludes the artery. When the pressure is slowly released, the Korotkoff sounds or oscillometric wave form produced is interpreted as sytolic and diastolic blood pressures.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The cuff is placed either over the upper arm, wrist, or thigh.

Regulation Number: 870.1120

Third Party Flag: Y

Medical Specialty: CV

Device Id: 20884838003020

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A