DEVICE: HemoCue® Hb 301 Microcuvettes (17311091118018)

Device Identifier (DI) Information

HemoCue® Hb 301 Microcuvettes
111801
In Commercial Distribution
111801
Hemocue AB
17311091118018
GS1

50
356164426 *Terms of Use
HemoCue Hb 301 Microcuvettes 4x50 vial
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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?
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
GKR System, Hemoglobin, Automated
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
BK060048 0
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: An unopened vial of microcuvettes can be stored for a shorter period of time (6 weeks) between -18-50°C (0-122°F).
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Storage Environment Temperature: between 10 and 40 Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3930944f-a679-4ac1-8683-0d217ec37f08
July 06, 2018
3
May 31, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
07311091118011 4 17311091118018 In Commercial Distribution package
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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

[?]
Unit of Use DI Number: 27311091118015 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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