DEVICE: Evolv Upper Arm Blood Pressure Monitor (00073796270001)
Device Identifier (DI) Information
Evolv Upper Arm Blood Pressure Monitor
BP7000
In Commercial Distribution
Omron Healthcare, Inc.
BP7000
In Commercial Distribution
Omron Healthcare, Inc.
No description.
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? |
---|---|---|---|---|
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.
|
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 [?] |
---|---|
K162092 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal |
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity |
Handling Environment Temperature: between 10 and 40 Degrees Celsius |
Handling Environment Temperature: between 50 and 104 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
b42f14a8-1ce5-4435-8235-3ece2ef529f7
November 08, 2019
4
December 06, 2016
November 08, 2019
4
December 06, 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 |
---|---|---|---|---|---|
10073796270008 | 10 | 00073796270001 | In Commercial Distribution | Case |
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
[?]
847-634-4350
ohiquality@omron.com
ohiquality@omron.com