REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838031922
• Version / Model: R450600
• Catalog Number: R450600
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-03
• Public Version: 2
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 91da1045-5682-4c12-ab4c-a2e45ae4850f
• Distribution End Date: 2023-01-20

Device Description

OADC Enrichment (2ml) PK/10

Device Characteristics

• Single Use: No
• 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: Yes
• 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
JSK	Supplement, Culture Media	Microbiology	866.2450	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58556	Culture medium antimicrobial supplement IVD	A culture medium supplement containing one or multiple antimicrobials that is intended to be used to suppress or inhibit the growth of native or resident microorganisms present in a clinical specimen to enhance recovery, isolation, and/or growth of pathogenic organisms.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838031922	GS1