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

GUDID 05032384580231

OXOID LIMITED

Antibacterial susceptibility testing disc IVD

• Primary Device ID: 05032384580231
• NIH Device Record Key: ec37879e-fd10-4045-a542-5f80b030566c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs
• Version Model Number: CT1954B
• Company DUNS: 365355452
• Company Name: OXOID LIMITED
• Device Count: 5
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com
• Phone: +441256694238
• Email: oxoid.techsupport@thermofisher.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384516018 [Primary]
GS1	05032384580231 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193508

FDA Product Code

• JTN: Susceptibility Test Discs, Antimicrobial

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-05
• Device Publish Date: 2024-10-28

Devices Manufactured by OXOID LIMITED

• 05032384128006 - Microbact Staph 12S: 2024-11-05
• 05032384128013 - Microbact Staph Fast Blue Reagent: 2024-11-05
• 05032384580231 - Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs: 2024-11-05
• 05032384580231 - Oxoid Eravacycline Disc (20ug) ERV20 Antimicrobial Susceptibility Test Discs: 2024-11-05
• 05032384579945 - Oxoid Sulbactam/Durlobactam (10/10ug) SUD20 Antimicrobial Susceptibility Test Di: 2024-11-05
• 05032384526123 - Oxoid Lefamulin (20ug) LMU20 Antimicrobial Susceptibility Test Discs: 2024-10-09
• 05032384002092 - Desoxycholate Citrate Agar (Hynes): 2024-08-21
• 05032384011414 - Campylobacter Selective Supplement (Skirrow): 2024-08-21
• 05032384028467 - Oxoid™ (8 Places, 90 mm skirt) Antimicrobial Susceptibility Disc Dispenser: 2024-08-21