BLOOD FREE CAMPY SELECT AGAR

GUDID 05032384003990

OXOID LIMITED

Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD Enriched agar culture medium IVD

• Primary Device ID: 05032384003990
• NIH Device Record Key: 46e9ce57-764b-480b-994f-ec15c35b915f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLOOD FREE CAMPY SELECT AGAR
• Version Model Number: CM0739B
• 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	05032384003990 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K850658

FDA Product Code

• JSG: Culture Media, Non-Selective And Non-Differential

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