BD FCT 445388

GUDID 58053326011820

BD FCT - Stool collection and preservation, 2 mL + regular flocked swab

COPAN ITALIA SPA

Rectal/faecal specimen collection kit

• Primary Device ID: 58053326011820
• NIH Device Record Key: 9b66b5c6-7f07-411b-b6e3-4051e181533e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD FCT
• Version Model Number: 445388
• Catalog Number: 445388
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 100
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	18053326011822 [Unit of Use]
GS1	38053326011826 [Primary]
GS1	58053326011820 [Package]; Contains: 38053326011826; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142094

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-03
• Device Publish Date: 2026-01-26

Devices Manufactured by COPAN ITALIA SPA

• 58053326011820 - BD FCT: 2026-02-03BD FCT - Stool collection and preservation, 2 mL + regular flocked swab
• 58053326011820 - BD FCT: 2026-02-03 BD FCT - Stool collection and preservation, 2 mL + regular flocked swab
• 08053326011771 - LBM CABroth: 2025-09-30
• 58053326011653 - CLASSIQSwab: 2025-07-11
• 58053326011660 - CLASSIQSwabs™ FLOQ Swabs®: 2025-07-11
• 58053326009551 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml
• 18053326009867 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One flexible flocked swab, breaking point 100 mm
• 18053326010283 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One regular flocked swab, breaking point 80 mm
• 08053326010446 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3 ml