DEVICE: HemoCue® Hb 201+ Analyzer (07311091217219)
Device Identifier (DI) Information
HemoCue® Hb 201+ Analyzer
121721
In Commercial Distribution
121721
Hemocue AB
121721
In Commercial Distribution
121721
Hemocue AB
HemoCue Hb 201+ Analyzer g/dL
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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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? |
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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 |
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GKR | System, Hemoglobin, Automated |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K032203 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: The analyzer should not be stored at high (i.e. >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
c4127e04-c6e9-4d92-b23e-376bc665392a
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