GUDID 05032384078912

OXOID LIMITED

Gatifloxacin susceptibility testing disc IVD

• Primary Device ID: 05032384078912
• NIH Device Record Key: dbeedfda-9947-4b06-b151-26cee2cc78f4
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CT1584S
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384078912 [Primary]
GS1	05032384502684 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000930

FDA Product Code

• JTN: Susceptibility Test Discs, Antimicrobial

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by OXOID LIMITED

• 05032384028900 - Oxoid™ (6 Places, 100 mm skirt) Antimicrobial Susceptibility Disc Dispenser: 2024-07-23
• 05032384028917 - Oxoid™ (8 Places, 100 mm skirt) Antimicrobial Susceptibility Disc Dispenser: 2024-07-23
• 05032384029723 - Oxoid™ (6 Places, 90 mm skirt) Antimicrobial Susceptibility Disc Dispenser: 2024-07-23
• 05032384034819 - Oxoid™ (12 places, 150 mm skirt) Antimicrobial Susceptibility Disc Dispenser: 2024-07-23
• 05032384188796 - Oxoid™ Bacitracin Diagnostic Discs: 2024-07-16
• 05032384574964 - Ceftazidime (10 ug) CAZ10 Antimicrobial Susceptibility Test Discs: 2024-07-15
• 05032384519828 - ProSpecT™ Wash Buffer: 2024-07-15
• 05032384503032 - IMAGEN CHLAMYDIA POSITIVE CONTROL SLIDE: 2024-07-11