BORDETELLA SELECTIVE SUPPLEMENT

GUDID 05032384011490

OXOID LIMITED

Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD Culture medium antimicrobial supplement IVD

• Primary Device ID: 05032384011490
• NIH Device Record Key: a27d4a2c-c8d3-442c-b3cd-37054d146667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BORDETELLA SELECTIVE SUPPLEMENT
• Version Model Number: SR0082E
• Company DUNS: 365355452
• Company Name: OXOID LIMITED
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05032384011490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K800265

FDA Product Code

• JSK: Supplement, Culture Media

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: 2022-12-12
• Device Publish Date: 2022-12-04

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