ONE
ONE-CUF - ONE-P1-2A
Device Description
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 typically wrapped around the upper arm of the patient. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXQ
Device Name: Blood Pressure Cuff
Device Class: 2
Physical State: N/A
Definition: 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: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1120
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00195278571403
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
Device Id: 00195278576507
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00195278571403
Package Quantity: 20
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A