Roche 9180 Potassium electrode

Basic Information

• Brand Name: Roche 9180 Potassium electrode
• Primary DI: 04015630028689
• Version / Model: 03110338180
• Catalog Number: 03110338180
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-07-30
• Public Version: 1
• Public Version Date: 2021-08-09
• Public Version Status: New
• Public Device Record Key: b01f5ad2-8b42-4ae5-9bd5-b7f5943f48c8

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
CEM	ELECTRODE, ION SPECIFIC, POTASSIUM	Clinical Chemistry	862.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52892	Potassium (K+) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen, 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	04015630028689	GS1