Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs

Basic Information

• Brand Name: Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs
• Primary DI: 05032384516018
• Version / Model: CT1954B
• Company Name: OXOID LIMITED
• Labeler DUNS: 365355452
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2024-10-28
• Public Version: 1
• Public Version Date: 2024-11-05
• Public Version Status: New
• Public Device Record Key: ec37879e-fd10-4045-a542-5f80b030566c

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
63834	Antibacterial susceptibility testing disc IVD	A susceptibility testing disc impregnated with a defined amount of a specific an antibacterial, also known as an antibiotic (i.e., a drug intended for treatment and/or prevention of a bacterial infection) intended to be used to determine the susceptibility of a specific bacterial organism (excluding mycobacteria) isolated from a clinical specimen by culture, using a disc diffusion method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	05032384580231	GS1
Primary	05032384516018	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K193508	000