NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838076824
• Version / Model: R01830
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b8b84ab7-70ab-4b8f-a3f6-92921cea38b4

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
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	866.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58573	Chromogenic VRE agar culture medium IVD	A selective and/or differential agar culture medium containing specified chromogenic substrates intended to be used to screen for the presence of Vancomycin-resistant Enterococci (VRE) in a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838076824	GS1
Unit of Use	00848838099526	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K092819	000