DEVICE: HemoCue® Hb 201 DM Analyzer (07311091211460)
Device Identifier (DI) Information
HemoCue® Hb 201 DM Analyzer
121146
In Commercial Distribution
121146
Hemocue AB
121146
In Commercial Distribution
121146
Hemocue AB
HemoCue Hb 201 DM Analyzer g/L
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
32435 | Haemoglobin analyser IVD, point-of-care |
A mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used by health professionals at the point-of-care, and often also in the laboratory, to determine the concentration of haemoglobin in a clinical specimen, using technology which may include colorimetry, electrometry or photometry.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
GKR | System, Hemoglobin, Automated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K041234 | 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
ada64872-eea8-4a14-bb0d-fe0569805fca
July 06, 2018
3
May 31, 2016
July 06, 2018
3
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