DEVICE: HemoCue® Hb 201+ Analyzer (07311091217202)

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Device Identifier (DI) Information

HemoCue® Hb 201+ Analyzer
121720
121720
Hemocue AB
07311091217202
GS1
1
HemoCue Hb 201+ Analyzer g/L
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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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FDA Product Code

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Product Code Product Code Name
GKR System, Hemoglobin, Automated
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
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
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
May 31, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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