NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838093333
• Version / Model: R01187
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• 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: 9ab84a44-83e4-494c-a5be-5f4b7a7dbfad

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
58546	Bile esculin/azide Enterococcus species agar culture medium IVD	A selective and/or differential agar culture medium containing bile esculin and azide intended to be used for the growth and isolation of Enterococci bacteria from a clinical specimen which contains heavy faecal contamination.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838093333	GS1
Unit of Use	00848838099885	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K972359	000