REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838012136
• Version / Model: R08518
• Catalog Number: R08518
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-04
• Public Version: 2
• Public Version Date: 2023-08-02
• Public Version Status: Update
• Public Device Record Key: c20fec08-641e-49f9-9a41-4cc83a9dca68
• Distribution End Date: 2023-04-17

Device Description

LJ Medium w/5% NaCl (slant) 20/PK

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
KZI	Culture Media, Enriched	Microbiology	866.2330	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58688	Enriched agar culture medium IVD	An agar culture medium supplemented with nutrient-rich substances (e.g., blood, serum) intended to enhance the growth and isolation of fastidious microorganisms from a clinical specimen and/or culture isolate. It is typically used to cultivate microorganisms that would not otherwise grow on general-purpose agar medium.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838012136	GS1