AccessGUDID - DEVICE: ChloroChek® Standard Solution, 100 mmol/L, 10x1mL (03661540304101)

GUDID

Device Identifier (DI) Information

Brand Name: ChloroChek® Standard Solution, 100 mmol/L, 10x1mL
Version or Model: SS-251
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ELITECHGROUP INC.

Primary DI Number: 03661540304101
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 052423787 *Terms of Use

Device Description: ELITechGroup Inc CHLOROCHEK Standard Solution is an aqueous solution used to conditioning or check the performance of ChloroChek Chloridometer by qualified personnel.

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):	No
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?
52877	Chloride (Cl-) 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 chloride (Cl-) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIS	Calibrator, Primary

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121823	000

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
Storage Environment Temperature: between -20 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 151ad4ae-fdde-4119-af50-0ab999c63d6b
Public Version Date: March 01, 2021
Public Version Number: 1
DI Record Publish Date: February 19, 2021