DEVICE: Omron Scale with Bluetooth (00073796931506)
Device Identifier (DI) Information
Omron Scale with Bluetooth
SC-150
In Commercial Distribution
SC-150
Omron Healthcare, Inc.
SC-150
In Commercial Distribution
SC-150
Omron Healthcare, Inc.
Weight scale with wireless communication - Bluetooth
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
38211 | Stand-on floor scale, electronic |
An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FRI | Scale, Stand-On, Patient |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Handling Environment Temperature: between 41 and 104 Degrees Fahrenheit |
Handling Environment Temperature: between 5 and 40 Degrees Celsius |
Handling Environment Humidity: between 30 and 85 Percent (%) Relative Humidity |
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between -20 and 60 Degrees Celsius |
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
8d81a23a-7d00-4760-a654-de71fb33d82c
June 09, 2021
1
June 01, 2021
June 09, 2021
1
June 01, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10073796931503 | 6 | 00073796931506 | 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
[?]
800-634-4350
ohiquality@omron.com
ohiquality@omron.com