AccessGUDID - DEVICE: ISE Potassium Electrode (00657498001905)

GUDID

Device Identifier (DI) Information

Brand Name: ISE Potassium Electrode
Version or Model: 20270476
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 20270476
Company Name: STANBIO LABORATORY, L.P.

Primary DI Number: 00657498001905
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045361136 *Terms of Use

Device Description: Ion-Selective Electrode for the measurement of potassium in serum.

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:	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?
59248	Potassium (K+) electrode IVD	An electrochemical sensor intended to be used to selectively measure electrical potential against a reference electrode to determine the concentration of potassium (K+) ions in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEM	Electrode, Ion Specific, Potassium

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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ce76c5ca-5083-4041-bc1d-911879c36e2c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016