Electrode for ABL analyzers

Basic Information

• Brand Name: Electrode for ABL analyzers
• Primary DI: 05700699456335
• Version / Model: 945-633
• Catalog Number: 945-633
• 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: 3
• Public Version Date: 2022-06-22
• Public Version Status: Update
• Public Device Record Key: 71e36eb3-9189-4b40-9af3-a29b0fb1a575
• Distribution End Date: 2020-01-16

Device Description

E115 Reference electrode for ABL5, BPH5

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: No
• 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
59241	Reference electrode IVD	An electrochemical sensor intended to be used as a known reference for electrical potential in an assay that is used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699456335	GS1

Customer Contacts

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