AccessGUDID - DEVICE: Electrode for ABL analyzers (05700699456120)

GUDID

Device Identifier (DI) Information

Brand Name: Electrode for ABL analyzers
Version or Model: 945-612
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 945-612
Company Name: Radiometer Medical ApS

Primary DI Number: 05700699456120
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: E788 pCO2 electrode for ABL7XX/8XX

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?
54500	Blood gas pCO2 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 partial pressure of carbon dioxide (pCO2) 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
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
GHS	ASSAY, CARBOXYHEMOGLOBIN
CIG	DIAZO COLORIMETRY, BILIRUBIN
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGA	GLUCOSE OXIDASE, GLUCOSE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KQI	ASSAY, FETAL HEMOGLOBIN
KHP	ACID, LACTIC, ENZYMATIC METHOD

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: 43420141-f010-4896-a4a7-958b51e76653
Public Version Date: November 27, 2020
Public Version Number: 3
DI Record Publish Date: September 01, 2016