REF 943-696 S5332 Cleaning Solution - Alcaline

Basic Information

• Brand Name: REF 943-696 S5332 Cleaning Solution - Alcaline
• Primary DI: 05700699436962
• Version / Model: 943-696
• Catalog Number: 943-696
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-09-21
• Public Version: 2
• Public Version Date: 2022-06-22
• Public Version Status: Update
• Public Device Record Key: 70bbeb2e-43bd-42cf-8c36-aafd30d99d73
• Distribution End Date: 2020-01-16

Device Description

S5332 Cleaning Solution for electrolyte analyzer 100mL

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

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	05700699436962	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 32 Degrees Celsius