Remel

Basic Information

• Brand Name: Remel
• Primary DI: 00848838058196
• Version / Model: R8311006
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2021-11-12
• Public Version: 2
• Public Version Date: 2021-12-08
• Public Version Status: Update
• Public Device Record Key: 11fd9e61-38fa-42ce-bc4f-6e74b584e047

Device Description

RapID ONE System 20/KT

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: No
• 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
JSS	Kit, Identification, Enterobacteriaceae	Microbiology	866.2660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
50415	Multiple Enterobacteriaceae species culture isolate identification IVD, kit	A collection of reagents and other associated materials intended to be used for the differentiation and/or identification of one or multiple species of oxidase negative, gram negative bacteria belonging to the Enterobacteriaceae family, that have been isolated by culture from a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30848838058197	GS1
Primary	00848838058196	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]