Remel

Basic Information

• Brand Name: Remel
• Primary DI: 00842558108605
• Version / Model: R01812
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2022-04-25
• Public Version: 1
• Public Version Date: 2022-05-03
• Public Version Status: New
• Public Device Record Key: d505437e-b3d7-40f4-a133-c98128f23195

Device Description

SPECTRA Strep A Agar 10/PK

Device Characteristics

• Single Use: Yes
• 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
JSJ	Culture Media, Selective And Non-Differential	Microbiology	866.2360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
58585	Differential/selective agar culture medium IVD	An agar culture medium intended to be used to promote the selective growth of a microbial species with specific characteristics (e.g., antibiotic resistance, ability to utilize, synthesize specific metabolites) and/or distinguish between microbial species growing on the same medium by appearance (e.g., colour, shape, growth pattern). It typically contains substances to inhibit the growth of commensal or contaminating microorganisms (e.g., antimicrobials, dyes, salts) and/or dyes or chemical indicators for differentiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	30842558108606	GS1
Primary	00842558108605	GS1

Customer Contacts

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