DEVICE: Synermed® (05060500090579)

Device Identifier (DI) Information

Synermed®
IR060-R
In Commercial Distribution
IR060-R
INFRARED LABORATORY SYSTEMS LLC
05060500090579
GS1

1
014210494 *Terms of Use
Cholesterol Reagent 3 X 250 mL + 3 X 100 mL
CLOSE

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 cholesterol lipid 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 cholesterol lipid in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CHH Enzymatic Esterase--Oxidase, Cholesterol
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K903015 000
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 0 and 4 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

9cbf6f1c-b52f-4132-bef9-c9b9e2fc2376
July 06, 2018
3
September 20, 2016
CLOSE

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
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

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

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

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