T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC

Basic Information

• Brand Name: T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC
• Primary DI: 00848838090981
• Version / Model: T8006 Sensititre™ Cation Adjusted Mueller-Hinton w/ TES w/ OADC
• Company Name: REMEL, INC.
• Labeler DUNS: 065769564
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-16
• Public Version: 1
• Public Version Date: 2025-01-24
• Public Version Status: New
• Public Device Record Key: fd16cba1-4560-4bc8-b233-dda6c2c59e10

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JTZ	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth	Microbiology	866.1700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58641	Mueller-Hinton broth antimicrobial susceptibility culture medium IVD	A non-selective Mueller-Hinton broth culture medium intended to be used to perform diagnostic antimicrobial susceptibility testing on non-fastidious microorganisms in a clinical specimen and/or culture isolate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00848838090981	GS1