DEVICE: Hemochron Whole Blood Microcoagulation System (10711234103029)

Device Identifier (DI) Information

Hemochron Whole Blood Microcoagulation System
J103C
In Commercial Distribution
J103C
ACCRIVA DIAGNOSTICS HOLDINGS, INC.
10711234103029
GS1

45
079299318 *Terms of Use
Citrate APTT Cuvette - 45 test cuvettes/box.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Activated partial thromboplastin time (APTT) IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the activated partial thromboplastin time (APTT) of a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
GFO Activated Partial Thromboplastin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K972831 000
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 35 and 46 Degrees Fahrenheit
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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

279aeab3-ab69-40ee-9b67-859c01c67bba
July 06, 2018
3
September 22, 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
No Package DIs found
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Secondary DI

[?]
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: 00711234103022 CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1-800-643-1640
UDI@accriva.com
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