REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838009587
• Version / Model: R064430
• Catalog Number: R064430
• 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: 4ab5595d-f14d-4c96-ab3e-611ee1e81798

Device Description

Saline,0.85% (1ml) 100/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
LIB	Device, General Purpose, Microbiology, Diagnostic	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62707	Culture medium base ingredient IVD	A substance intended to be used as an ingredient in the formulation of a broth or agar culture medium to support, promote, and monitor the growth of microorganisms in culture. Substances typically include nutrients, buffering agents, salts, minerals and indicators.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838009587	GS1