S53516 10mL REF 943-905 Electrode Cleaner

Basic Information

• Brand Name: S53516 10mL REF 943-905 Electrode Cleaner
• Primary DI: 05700699439055
• Version / Model: 943-905
• Catalog Number: 943-905
• 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: 2022-08-15
• Public Version Status: Update
• Public Device Record Key: 4ebb2562-cf53-4eeb-83ba-377639f1a97b
• Distribution End Date: 2020-01-16

Device Description

Electrode Cleaner (pH, pO2, pCO2) for BPH5, ABL5/50/5XX S53516

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
30026	Domestic refuse/waste disposal assistive device	A non-electric-powered device designed to be used by a person with a disability person for the purpose of storing or disposing of waste material, e.g., a refuse (garbage) waste disposal container.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699439055	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Irritating or corrosive products
• Type: Storage Environment Temperature
• Temperature Range: 2 – 32 Degrees Celsius