GUDID 05032384005819

OXOID LIMITED

Nitrofurantoin susceptibility testing disc IVD

• Primary Device ID: 05032384005819
• NIH Device Record Key: 4c7f3c34-3e84-4363-958c-aa53b0514c06
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CT0036B
• 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	05032384005819 [Primary]
GS1	05032384502554 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860153

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

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• 05032384502981 - IMAGEN Influenza Virus A and B: 2025-01-07
• 05032384082919 - ORSAB SELECTIVE SUPPLEMENT: 2024-11-06
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• 05032384128006 - Microbact Staph 12S: 2024-11-05