DIAGNOSTIX e
Diagnostix™ - 9002WK-MCC
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
- 95.00
- 15.00
- 122.00
- -4.00
Device Sizes
- 3 Cuff, 19-50cm
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: 00634782570576
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00634782070908
Package Quantity: 4
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Master Case
Device Id: 00634782070908
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