SOFT
SOFT-CUF - SFT-F1-2C
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 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.
Environmental Conditions
- 95.00
- 15.00
- 55.00
- -20.00
Device Sizes
- Forearm
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: 00840682105750
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00840682105446
Package Quantity: 20
Package Discontinue Date: 4/1/2025 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: N/A
Device Id: 00840682105446
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
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