AccessGUDID - DEVICE: ISE ELECTROLYTE BUFFEER REAGENT KIT 88810 (00817302020663)

GUDID

Device Identifier (DI) Information

Brand Name: ISE ELECTROLYTE BUFFEER REAGENT KIT 88810
Version or Model: 88810
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 88810
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302020663
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: ISE (Electrolytes) Buffer - CX3 Reagent 1 x 2000 mL

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?
58237	Buffered sample diluent IVD	A buffered diluent solution intended to be used as a consumable reagent during manual procedures or on-board an automated or semi-automated instrument (e.g., haematological cell analyser) for the processing, staining and/or testing of clinical laboratory specimens (e.g., whole blood).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
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 on board a clinical analyzer for 30 days
Special Storage Condition, Specify: Reagent is stable when stored at 8-30° C until expiration date
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2000 Milliliter
Device Size Text, specify: Kit contains 1 R1 and 1 package insert

Device Record Status

Public Device Record Key: 4782087b-3e55-4c6f-9621-64ee16707a04
Public Version Date: August 14, 2023
Public Version Number: 3
DI Record Publish Date: September 01, 2016