Cuff & Bladder
Advantage™ - 850-6023
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
- 85.00
- 15.00
- 131.00
- -4.00
Device Sizes
- Wide Range Adult, 22-45.9cm
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DXN
Device Name: System, Measurement, Blood-Pressure, Non-Invasive
Device Class: 2
Physical State: N/A
Definition: N/A
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: 870.1130
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 00634782562991
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00634782063184
Package Quantity: 15
Package Discontinue Date: 6/14/2023 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Master Case
Device Id: 00634782063184
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