NA

Basic Information

• Brand Name: NA
• Primary DI: 00848838077135
• Version / Model: R01173
• 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: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 96b0d7b7-00cd-4252-a351-f707587d8e5f

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
58551	Brain heart infusion (BHI) agar culture medium IVD	A nutrient agar culture medium containing brain and heart infusion intended to be used for the growth and isolation of fastidious microorganisms from a clinical specimen.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838077135	GS1
Unit of Use	00848838099427	GS1

Customer Contacts

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