GUDID 05032384006670

OXOID LIMITED

Ciprofloxacin susceptibility testing disc IVD

• Primary Device ID: 05032384006670
• NIH Device Record Key: 9125dfd2-e548-4d47-b5c1-8f5170323a64
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: CT0425B
• 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	05032384006670 [Primary]
GS1	05032384502325 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964492

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

• 05032384003433 - S S AGAR (MODIFIED): 2022-12-15
• 05032384003549 - PSEUDOMONAS AGAR BASE: 2022-12-15
• 05032384003648 - CLOSTRIDIUM DIFFICILE: 2022-12-15
• 05032384003730 - WILKINS CHALGREN ANAEROBE BROTH: 2022-12-15
• 05032384011476 - CHLORAMPHENICOL SELECTIVE SUPPLEMENT: 2022-12-15
• 05032384011483 - CHLORAMPHENICOL SELECTIVE SUPPLEMENT: 2022-12-15
• 05032384011674 - CAMPYLO.SEL.SUPP.(BLASER-WANG)1X10 VIALS: 2022-12-15
• 05032384011711 - PSEUDOMONAS C-N SEL.SUPPL. 1 X 10: 2022-12-15