NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838022371
• Version / Model: R21090
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-12-09
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 2c2c7e6b-b300-43f6-af2f-291928eb3f4f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
MJD	Culture Media, Antimycobacteria, Susceptibility Test	Microbiology	866.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62402	Niacin-production microbial reagent IVD	A substance or reactant intended to be used in microbial testing to detect niacin, produced by a microorganism isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838022371	GS1
Unit of Use	00848838099809	GS1

Customer Contacts

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