DEVICE: CVS Health (00050428266434)
Device Identifier (DI) Information
CVS Health
800231
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
800231
In Commercial Distribution
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Blood Pressure Monitor
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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45617 | Automatic-inflation electronic sphygmomanometer, portable, arm/wrist |
An electrically-powered device designed to noninvasively measure blood pressure using a self-contained software program that regulates automatic arm/wrist-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 designed to be portable (e.g., hand-held or carried in a pouch) and is often used for emergency services or home blood pressure monitoring.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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DXN | System, Measurement, Blood-Pressure, Non-Invasive |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit |
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity |
Storage Environment Atmospheric Pressure: between 86 and 106 KiloPascal |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
487b3ac8-2794-4794-ba0a-b09827fc8b5f
November 08, 2019
3
September 24, 2016
November 08, 2019
3
September 24, 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 |
---|---|---|---|---|---|
10050428266431 | 12 | 00050428266434 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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
[?]
1-800-536-0366
info@beurer.com
info@beurer.com