AccessGUDID - DEVICE: Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811 (00817302023220)

GUDID

Device Identifier (DI) Information

Brand Name: Carolina Liquid Chemistries Corp. ISE Reference Solution DT88811
Version or Model: DT88811
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DT88811
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302023220
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
59238	Ion selective electrode (ISE) reference solution IVD, reagent	A substance or reactant intended to be used together with a reference electrode to perform a specific function in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Reagent is stable when stored unopened at 10-30° C until expiration date.
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Kit contains 2L of ISE Reference Solution
Total Volume: 2 Liter

Device Record Status

Public Device Record Key: c5e2913e-3223-4822-980a-9827fcdac9d9
Public Version Date: May 18, 2020
Public Version Number: 1
DI Record Publish Date: May 08, 2020