DEVICE: Synermed® (05060500091576)

Device Identifier (DI) Information

Synermed®
IR960-CO2
In Commercial Distribution
IR960-CO2
INFRARED LABORATORY SYSTEMS LLC
05060500091576
GS1

1
014210494 *Terms of Use
CO2 Controls 12 X 15 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
Carbon dioxide (CO2) IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of bicarbonate (HCO3-) ions [as a measure of carbon dioxide (CO2) concentration] in a clinical specimen.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
JIX Calibrator, Multi-Analyte Mixture
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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

a35d3585-8a86-4f4d-a74d-9921298a7732
June 11, 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