REMEL

Basic Information

• Brand Name: REMEL
• Primary DI: 00848838022258
• Version / Model: R21052
• Catalog Number: R21052
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-01-03
• Public Version: 1
• Public Version Date: 2023-01-11
• Public Version Status: New
• Public Device Record Key: 962a9cae-1eb8-444a-9bae-b946eb5ca8c0

Device Description

Coagulase Plasma 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
JTL	Plasma, Coagulase, Human, Horse And Rabbit	Microbiology	866.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42737	Coagulase production microbial reagent IVD	A substance or reactant intended to be used in microbial testing to detect the enzyme coagulase, 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	00848838022258	GS1