AccessGUDID - DEVICE: Electrode for ABL/BPH5 analyzers (05700699453839)

GUDID

Device Identifier (DI) Information

Brand Name: Electrode for ABL/BPH5 analyzers
Version or Model: 945-383
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 945-383
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699453839
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: G707 pH electrode Color-coded Blue. For BPH5, ABL5/50/5XX

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?
54499	Blood gas pH IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of blood gas pH using an ion-selective electrode (ISE) method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
CGA	GLUCOSE OXIDASE, GLUCOSE
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 2 and 32 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22260842-65bb-4c1d-a997-e146a705f584
Public Version Date: June 22, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2016