DEVICE: HemoCue® WBC Analyzer (07311091230010)

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Device Identifier (DI) Information

HemoCue® WBC Analyzer
123001
123001
Hemocue AB
07311091230010
GS1
1
HemoCue WBC Analyzer x10^9 /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
Haematological cell analyser IVD, semi-automated A mains electricity (AC-powered) laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with reduced technician involvement and automation of some, but not all, procedural steps.
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FDA Product Code

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Product Code Product Code Name
GKL Counter, Cell, Automated (Particle Counter)
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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: Storage in <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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