AccessGUDID - DEVICE: CLC1600 Chemistry Analyzer with ISE Module (00817302023114)

GUDID

Device Identifier (DI) Information

Brand Name: CLC1600 Chemistry Analyzer with ISE Module
Version or Model: CLC1600
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CLC1600i
Company Name: CAROLINA LIQUID CHEMISTRIES CORPORATION

Primary DI Number: 00817302023114
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 962385787 *Terms of Use

Device Description: CLC1600 Clinical Chemistry Anallyzer with ISE

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:	No
Combination Product:	Yes
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?
52866	Multiple electrolyte IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen, using an ion-selective electrode (ISE) method.	Active	false
61927	Multi-modality clinical specimen analysis system IVD	An assembly of mains electricity (AC-powered) devices consisting of two or more analysers of different analytic modalities [e.g., immunoassay and photometric (clinical chemistry)] intended to be used for the qualitative and/or quantitative determination of chemical and/or biological markers (e.g., drug, hormone, microbial toxin, electrolytes) in a clinical specimen. The assembly may also include a sample preparation instrument, reagent management instrument, data processing and/or data display software. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
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
Storage Environment Temperature: between 8 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Depth: 35 Inch
Height: 44 Inch
Width: 50 Inch
Device Size Text, specify: CLC1600 Clinical Chemistry Anallyzer with ISE

Device Record Status

Public Device Record Key: 8bfb22a4-8825-443d-b077-87d85f465cb3
Public Version Date: May 24, 2024
Public Version Number: 3
DI Record Publish Date: December 05, 2016