All Purpose Cuff, 1 Tube
Diagnostix™ - 850-9000-10SARB
Device Description
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm-cuff inflation and measurement cycles. It typically displays current heart rate and mean arterial pressure in addition to systolic and diastolic blood pressures; it may have memory to store blood pressure values and may sound an alarm if blood pressure exceeds pre-set limits. This device is not designed to be portable and is typically used bedside.
Environmental Conditions
- 85.00
- 15.00
- 131.00
- -4.00
Device Sizes
- Small Adult Cuff, 17-25cm
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: 00634782564360
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00634782064570
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Master Case
Device Id: 00634782064570
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