DEVICE: 7 Series Plus Bluetooth Smart Blood Pressure Monitor (00073796267612)
Device Identifier (DI) Information
7 Series Plus Bluetooth Smart Blood Pressure Monitor
BP761N
In Commercial Distribution
BP761N
Omron Healthcare, Inc.
BP761N
In Commercial Distribution
BP761N
Omron Healthcare, Inc.
Upper arm blood pressure monitor with bluetooth
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 [?] |
---|---|
K133383 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal |
Storage Environment Humidity: between 10 and 95 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 70 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
12e26f2b-193c-42b7-84c0-9a2ea57a26f7
November 08, 2019
4
September 16, 2016
November 08, 2019
4
September 16, 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 |
---|---|---|---|---|---|
10073796267619 | 10 | 00073796267612 | In Commercial Distribution | Case | |
50073796267617 | 4 | 00073796267612 | In Commercial Distribution | boxes of 3 units |
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
[?]
1-800-634-4350
ohiquality@omron.com
ohiquality@omron.com