AccessGUDID - DEVICE: ABL80 FLEX CO-OX Analyzer (05700693938417)

GUDID

Device Identifier (DI) Information

Brand Name: ABL80 FLEX CO-OX Analyzer
Version or Model: 393-841
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 393-841
Company Name: Radiometer Medical ApS

Primary DI Number: 05700693938417
Issuing Agency: GS1
Commercial Distribution End Date: March 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: ABL80 FLEX CO-OX, Analyzer

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?
56667	Metabolic profile clinical chemistry analyser IVD	A portable, electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro measurement of multiple clinical chemistry analytes to generate a metabolic profile. Analytes may include pH, blood gas parameters (e.g., pO2, pCO2), electrolytes [e.g., Sodium (Na2+), potassium (K+), chloride (Cl-)], glucose, urea, creatinine and sometimes in addition haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
JPI	DEVICE, HEMATOCRIT MEASURING
DQA	Oximeter
CGA	GLUCOSE OXIDASE, GLUCOSE
JJI	ANALYZER, ENZYME, FOR CLINICAL USE
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
GLY	OXIMETER TO MEASURE HEMOGLOBIN
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JJY	Multi-analyte controls, all kinds (assayed)
GHS	ASSAY, CARBOXYHEMOGLOBIN
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
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
Special Storage Condition, Specify: Fragile

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fac6a9fc-6fec-4e00-bbe2-f9bd6814a406
Public Version Date: September 22, 2023
Public Version Number: 5
DI Record Publish Date: September 01, 2016