Adstation Oto PMV
Diagnostix™ - 5681X-36L8W
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
- 10.00
- 122.00
- 23.00
Device Sizes
No Data Available
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
Code: ERA
Device Name: Otoscope
Device Class: 1
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: EN
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: 874.4770
Third Party Flag: N
Medical Specialty: EN
Code: HLJ
Device Name: Ophthalmoscope, Battery-Powered
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 4
Review Panel: OP
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: 886.1570
Third Party Flag: N
Medical Specialty: OP
Device IdentifiersDevice Id: 00634782097172
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