NA

Basic Information

• Brand Name: NA
• Primary DI: 05032384005628
• Version / Model: CT0017B
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• 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: dbe9a95a-2288-403f-80f9-f97f8340d35b

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
JTN	Susceptibility Test Discs, Antimicrobial	Microbiology	866.1620	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45736	Colistin sulfate susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of the antimicrobial colistin sulfate, intended to be used to determine the antimicrobial susceptibility of a specific microorganism isolated from a clinical specimen by culture, using a disc diffusion method.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05032384005628	GS1
Unit of Use	05032384502042	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K860153	000