AccessGUDID - DEVICE: Electrode for ABL analyzers (05700699456632)

GUDID

Device Identifier (DI) Information

Brand Name: Electrode for ABL analyzers
Version or Model: 945-663
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 945-663
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699456632
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: E8089 Crea B electrode for ABL8XX

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?
53252	Creatinine IVD, reagent	A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of creatinine in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
CGA	GLUCOSE OXIDASE, GLUCOSE
KQI	ASSAY, FETAL HEMOGLOBIN
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
CIG	DIAZO COLORIMETRY, BILIRUBIN
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KHP	ACID, LACTIC, ENZYMATIC METHOD
GHS	ASSAY, CARBOXYHEMOGLOBIN
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7e242a96-9f1c-4bb4-9d40-94d9558e688c
Public Version Date: December 20, 2022
Public Version Number: 4
DI Record Publish Date: September 01, 2016