AccessGUDID - DEVICE: K ELECTRODE, ISE MODULE (05999883586693)

GUDID

Device Identifier (DI) Information

Brand Name: K ELECTRODE, ISE MODULE
Version or Model: K+ Electrode
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5202
Company Name: Diatron Medicinai Instrumentumok Laboratoriumi Diagnosztikai Fejleszto-Gyarto Zartkoruen Mukodo Reszvenytarsasag

Primary DI Number: 05999883586693
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 427395277 *Terms of Use

Device Description: Clinical Chemistry Test Systems / Potassium test system. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

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):	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?
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 [?]
K101741	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 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 60 Millimeter
Depth: 40 Millimeter
Width: 90 Millimeter

Device Record Status

Public Device Record Key: c9ef5ee3-6062-4ded-9369-5d0014614655
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: October 06, 2016