AccessGUDID - DEVICE: GENCHEM™ ISE Electrolyte Reference (00851445007259)

GUDID

Device Identifier (DI) Information

Brand Name: GENCHEM™ ISE Electrolyte Reference
Version or Model: GEN-ISE REFERENCE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: GEN-ISE REFERENCE
Company Name: GENCHEM INC

Primary DI Number: 00851445007259
Issuing Agency: GS1
Commercial Distribution End Date: August 19, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 193856866 *Terms of Use

Device Description: 10/17/2022

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
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
JFL	PH RATE MEASUREMENT, CARBON-DIOXIDE
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5b6c07cf-cdaf-4030-8e26-75bfb007fd0a
Public Version Date: October 21, 2022
Public Version Number: 4
DI Record Publish Date: September 10, 2016