AccessGUDID - DEVICE: ABL90 FLEX Analyzer (05700693930909)

GUDID

Device Identifier (DI) Information

Brand Name: ABL90 FLEX Analyzer
Version or Model: 393-090
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 393-090
Company Name: Radiometer Medical ApS

Primary DI Number: 05700693930909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 308667539 *Terms of Use

Device Description: ABL90 FLEX, Analyzer without casettes, cables, manuals etc.

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

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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.

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.

FDA Product Code

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Product Code	Product Code Name
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH
KHP	ACID, LACTIC, ENZYMATIC METHOD
JGS	ELECTRODE, ION SPECIFIC, SODIUM
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE
JFP	ELECTRODE, ION SPECIFIC, CALCIUM
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM
KQI	ASSAY, FETAL HEMOGLOBIN
JJY	Multi-analyte controls, all kinds (assayed)
CGA	GLUCOSE OXIDASE, GLUCOSE
GHS	ASSAY, CARBOXYHEMOGLOBIN
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM

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

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Storage and Handling
Handling Environment Temperature: between 15 and 32 Degrees Celsius
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 107 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Special Storage Condition, Specify: Environmental specification 30-32 °C: Barometric pressure 80.0-106.7 kPa. Environmental specification 15-30 °C: Barometric pressure 70.0-106.7 kPa

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 65a62230-1741-4952-85d1-c8823af178b0
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 01, 2016