Rinse Solution S4980 REF 944-130

Basic Information

• Brand Name: Rinse Solution S4980 REF 944-130
• Primary DI: 05700699441300
• Version / Model: 944-130
• Catalog Number: 944-130
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 1
• Public Version Date: 2018-10-22
• Public Version Status: New
• Public Device Record Key: 94b98b93-1726-4b53-a97b-889d4c987741

Device Description

S4980 Rinse Solution 600mL, for ABL800 FLEX

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
JFP	ELECTRODE, ION SPECIFIC, CALCIUM	Clinical Chemistry	862.1145	2
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2
CIG	DIAZO COLORIMETRY, BILIRUBIN	Clinical Chemistry	862.1110	2
CHL	Electrode measurement, blood-gases (pco2, po2) and blood ph	Clinical Chemistry	862.1120	2
GHS	ASSAY, CARBOXYHEMOGLOBIN	Hematology	864.7425	2
KHP	ACID, LACTIC, ENZYMATIC METHOD	Clinical Chemistry	862.1450	1
CGZ	ELECTRODE, ION-SPECIFIC, CHLORIDE	Clinical Chemistry	862.1170	2
KQI	ASSAY, FETAL HEMOGLOBIN	Hematology	864.7455	2
MQM	BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM	Clinical Chemistry	862.1113	1
CGA	GLUCOSE OXIDASE, GLUCOSE	Clinical Chemistry	862.1345	2
CGL	ELECTRODE, ION BASED, ENZYMATIC, CREATININE	Clinical Chemistry	862.1225	2
JGS	ELECTRODE, ION SPECIFIC, SODIUM	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699441300	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 32 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Warning biological hazard Single use