DEVICE: ABL80 FLEX Analyzer (05700693938394)

Download: XML | JSON

Device Identifier (DI) Information

ABL80 FLEX Analyzer
393-839
393-839
Radiometer Medical ApS
05700693938394
GS1
1
ABL80 FLEX Full panel, 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
GKR SYSTEM, HEMOGLOBIN, AUTOMATED
GHS ASSAY, CARBOXYHEMOGLOBIN
CGZ ELECTRODE, ION-SPECIFIC, CHLORIDE
DQA Oximeter
CEM ELECTRODE, ION SPECIFIC, POTASSIUM
CGA GLUCOSE OXIDASE, GLUCOSE
JJY Multi-analyte controls, all kinds (assayed)
JPI DEVICE, HEMATOCRIT MEASURING
JGS ELECTRODE, ION SPECIFIC, SODIUM
JFP ELECTRODE, ION SPECIFIC, CALCIUM
JIX CALIBRATOR, MULTI-ANALYTE MIXTURE
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