DEVICE: Oh’Care Lite Blood Glucose Test strips (00860396000615)
Device Identifier (DI) Information
Oh’Care Lite Blood Glucose Test strips
IGM-1003A
In Commercial Distribution
INFS003L
IJDREAM CORPORATION
IGM-1003A
In Commercial Distribution
INFS003L
IJDREAM CORPORATION
Blood Glucose Test strips
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
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? |
---|---|---|---|---|
53303 | Glucose IVD, kit, electrometry |
A collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFR | Glucose Dehydrogenase, Glucose |
NBW | System, Test, Blood Glucose, Over The Counter |
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 Temperature: between 36 and 86 Percent (%) Relative Humidity |
Clinically Relevant Size
[?]Size Type Text |
---|
Total Volume: 0.5 Microliter |
Device Record Status
7aa217aa-d264-4af6-b345-16a67c24998d
November 11, 2024
3
June 30, 2018
November 11, 2024
3
June 30, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
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
[?]
800-925-2949
support@ijdream.com
support@ijdream.com