DEVICE: HemoCue® Glucose 201 DM Analyzer (07311091214225)
Device Identifier (DI) Information
HemoCue® Glucose 201 DM Analyzer
121422
In Commercial Distribution
121422
Hemocue AB
121422
In Commercial Distribution
121422
Hemocue AB
HemoCue Glucose 201 DM Analyzer mg/dL plasma
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
62538 | Glucose monitoring system IVD, point-of-care |
A collection of devices including a portable, electrically-powered instrument (meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used exclusively at the point-of-care by medical professionals for the quantitative measurement of glucose singularly in a whole blood clinical specimen. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LFR | Glucose Dehydrogenase, Glucose |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K041230 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Storage in <90 % non-condensing humidity |
Storage Environment Temperature: between 32 and 122 Degrees Fahrenheit |
Storage Environment Temperature: between 0 and 50 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
02a7fb62-d5a9-467a-b5e5-321913904799
October 31, 2022
4
May 31, 2016
October 31, 2022
4
May 31, 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 |
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No Package DIs found |
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
[?]
No Customer Contact currently defined