ABL80 FLEX SP80 CO-OX

Basic Information

• Brand Name: ABL80 FLEX SP80 CO-OX
• Primary DI: 05700699442529
• Version / Model: 944-252
• Catalog Number: 944-252
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2020-11-27
• Public Version Status: Update
• Public Device Record Key: 16864874-1f86-4946-9fcc-12ae411278da

Device Description

ABL80 FLEX Solution pack CO-OX

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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CHL	ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH	Clinical Chemistry	862.1120	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
DQA	Oximeter	Cardiovascular	870.2700	2
GLY	OXIMETER TO MEASURE HEMOGLOBIN	Hematology	864.7500	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
JPI	DEVICE, HEMATOCRIT MEASURING	Hematology	864.6400	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
JJI	ANALYZER, ENZYME, FOR CLINICAL USE	Clinical Chemistry	862.2500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
52858	Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies	A collection of reagents and other associated materials intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample, using multiple technologies such as ion-selective electrode (ISE) and haemoximetry in a single analyser. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699442529	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 25 Degrees Celsius