DEVICE: Walgreens (04719872483038)
Device Identifier (DI) Information
Walgreens
WGNBPA-960BT
In Commercial Distribution
HEALTH & LIFE CO., LTD.
WGNBPA-960BT
In Commercial Distribution
HEALTH & LIFE CO., LTD.
Arm type Blood pressure monitor
Device Characteristics
MR Unsafe | |
No | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16173 | Automatic-inflation electronic sphygmomanometer, non-portable |
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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXN | System, Measurement, Blood-Pressure, Non-Invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 700 and 1060 KiloPascal |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
aac36560-fdd4-44a0-919c-ef632ecfd969
August 14, 2023
5
June 13, 2016
August 14, 2023
5
June 13, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14719872483035 | 4 | 04719872483038 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined