Sensititre

Basic Information

• Brand Name: Sensititre
• Primary DI: M578CMC2CCHF2
• Version / Model: CMC2CCHF
• Company Name: TREK DIAGNOSTIC SYSTEMS LIMITED
• Labeler DUNS: 298203498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-11-08
• Public Version Status: Update
• Public Device Record Key: 0eca0a22-b880-43d5-b3d9-4bf1ec4bf299

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: 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
JWY	Manual Antimicrobial Susceptibility Test Systems	Microbiology	866.1640	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43685	Bacterial species culture isolate identification/antimicrobial susceptibility profile IVD, kit	A collection of reagents and other associated materials intended to be used to determine the identification and antimicrobial susceptibility profile of bacterial species isolated from a clinical specimen by culture.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M578CMC2CCHF2	HIBCC
Unit of Use	M578CMC2CCHF0	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K150236	000