AccessGUDID - DEVICE: Chloride Electrode (08430215043561)

GUDID

Device Identifier (DI) Information

Brand Name: Chloride Electrode
Version or Model: 3246353001
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3246353001
Company Name: Roche Diagnostics GmbH

Primary DI Number: 08430215043561
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315028860 *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:	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?
59240	Chloride (Cl-) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of chloride (Cl-) ions in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060373	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 7 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4028d69d-96d1-4c42-bf8e-ec1248c7f6d8
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 20, 2016