DEVICE: ABL80 FLEX CO-OX Analyzer (05700693938417)

Download: XML | JSON

Device Identifier (DI) Information

ABL80 FLEX CO-OX Analyzer
393-841
393-841
Radiometer Medical ApS
05700693938417
GS1
1
ABL80 FLEX CO-OX, Analyzer
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Metabolic profile clinical chemistry analyser IVD, portable, automated A portable mains electricity (AC-powered) laboratory instrument, typically with rechargeable batteries for power at the point-of-care in acute care settings, intended 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 haemoximetry parameters [e.g., carboxy-haemoglobin (COHb), methaemoglobin (MetHb), total haemoglobin (totHb), hematrocrit (Hct)]. It operates with minimal technician involvement and automation of all procedural steps.
CLOSE

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
CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Special Storage Condition, Specify: Fragile
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Status

In Commercial Distribution
September 01, 2016

CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+459999999999
radiometer@radiometer.dk
CLOSE