ABL90 FLEX PLUS Analyzer

Basic Information

• Brand Name: ABL90 FLEX PLUS Analyzer
• Primary DI: 05700693930923
• Version / Model: 393-092
• Catalog Number: 393-092
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-15
• Public Version: 4
• Public Version Date: 2022-09-16
• Public Version Status: Update
• Public Device Record Key: 788523a7-263f-413c-8900-4ad2e6a84dd8

Device Description

ABL90 FLEX PLUS, Analyzer without casettes, cables, manuals etc.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
KQI	ASSAY, FETAL HEMOGLOBIN	Hematology	864.7455	2
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700693930923	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Labeling does not contain MRI Safety information
• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 32 Degrees Celsius
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 107 KiloPascal
• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity