ABL80 SC80

Basic Information

• Brand Name: ABL80 SC80
• Primary DI: 05700699456915
• Version / Model: 945-691
• Catalog Number: 945-691
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 4
• Public Version Date: 2022-09-23
• Public Version Status: Update
• Public Device Record Key: 57e978fc-9514-4e1c-9e27-2c23737868c9
• Distribution End Date: 2022-06-24

Device Description

SC80 100/30 BG/Hct, no QC3

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
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
GKR	SYSTEM, HEMOGLOBIN, AUTOMATED	Hematology	864.5620	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
JJY	Multi-analyte controls, all kinds (assayed)	Clinical Chemistry	862.1660	1
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
JPI	DEVICE, HEMATOCRIT MEASURING	Hematology	864.6400	2
JIX	CALIBRATOR, MULTI-ANALYTE MIXTURE	Clinical Chemistry	862.1150	2
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
DQA	Oximeter	Cardiovascular	870.2700	2

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	05700699456915	GS1

Customer Contacts

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

Storage Conditions

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