DEVICE: Synermed® (05060500090685)

Device Identifier (DI) Information

Synermed®
UV310-WK
In Commercial Distribution
UV310-WK
INFRARED LABORATORY SYSTEMS LLC
05060500090685
GS1

1
014210494 *Terms of Use
Creatine Kinase Reagent 3 X 25 mL + 3 X 12.5 mL + 3 wedges
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Total creatine kinase (CK) 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 total creatine kinase (CK) in a clinical specimen.
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FDA Product Code

[?]
Product Code Product Code Name
CGS Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K930932 000
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 4 Degrees Celsius
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Clinically Relevant Size

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

d3c35900-ff5c-40ea-84c5-864bb33cacb6
July 06, 2018
3
September 20, 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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
317 896-1565
info@irlabsystems.com
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