GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent

Basic Information

• Brand Name: GENCHEM™ Electrode, Ion Specific, Urea Nitrogen (BUN) reagent
• Primary DI: 00851445007075
• Version / Model: GEN-BUN3
• Catalog Number: GEN-BUN3
• Company Name: GENCHEM INC
• Labeler DUNS: 193856866
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-19
• Public Version: 5
• Public Version Date: 2022-10-21
• Public Version Status: Update
• Public Device Record Key: dc95cc5f-9632-4982-8116-9a5df08cfa42
• Distribution End Date: 2020-08-19

Device Description

10/17/2022

Device Characteristics

• Single Use: Yes
• 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
CDS	ELECTRODE, ION SPECIFIC, UREA NITROGEN	Clinical Chemistry	862.1770	2

GMDN Terms

Code	Name	Definition	Implantable	Status
53590	Urea IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of urea or urea nitrogen [also known as blood urea nitrogen (BUN)] in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851445007075	GS1

Customer Contacts

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