Membrane for E808 electrode

Basic Information

• Brand Name: Membrane for E808 electrode
• Primary DI: 05700699420435
• Version / Model: 942-043
• Catalog Number: 942-043
• Company Name: Radiometer Medical ApS
• Labeler DUNS: 308667539
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-09-01
• Public Version: 3
• Public Version Date: 2022-06-24
• Public Version Status: Update
• Public Device Record Key: 8e25565b-1a6a-4550-8570-f5b2b0b46288
• Distribution End Date: 2020-01-16

Device Description

D888 Membrane box for E808 pCO2 electrode for ABL5/50/5XX

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
54500	Blood gas pCO2 IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of blood gas partial pressure of carbon dioxide (pCO2) using an ion-selective electrode (ISE) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05700699420435	GS1
Unit of Use	55700699420430	GS1

Customer Contacts

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

Storage Conditions

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