REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838022289
• Version / Model: R21068
• Catalog Number: R21068
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-04
• Public Version: 1
• Public Version Date: 2023-01-12
• Public Version Status: New
• Public Device Record Key: 94bec43e-52f7-4f63-88a0-984a0f5c24c1

Device Description

Germ Tube Solution 25ml/VL

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
JXC	Kit, Screening, Yeast	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37383	Yeast species culture isolate identification/antimicrobial susceptibility profile IVD, kit	A collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of a Yeast species 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	00848838022289	GS1