DEVICE: Synermed® (05060500090388)

Device Identifier (DI) Information

Synermed®
IR700-L
In Commercial Distribution
IR700-L
INFRARED LABORATORY SYSTEMS LLC
05060500090388
GS1

1
014210494 *Terms of Use
Total Bilirubin Reagent 6 X 1000 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 bilirubin 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 bilirubin in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
CIG Diazo Colorimetry, Bilirubin
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K972716 000
No CLOSE

Sterilization

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

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 20 and 25 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

35789a27-df0b-4892-8bcc-77bad9622c33
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