Membrane for E155 electrode

Basic Information

• Brand Name: Membrane for E155 electrode
• Primary DI: 05700699420671
• Version / Model: 942-067
• Catalog Number: 942-067
• 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: 2022-06-22
• Public Version Status: Update
• Public Device Record Key: dc405f21-c3bd-43af-9444-16d1d6e8e06c
• Distribution End Date: 2020-01-16

Device Description

D115 Membrane box for 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: 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
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	05700699420671	GS1
Unit of Use	55700699420676	GS1

Customer Contacts

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

Storage Conditions

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