FecalSwab® 4C024S10

GUDID 38053326002206

2 ml modified Cary Blair Orange Cap+Flocked Swab

COPAN ITALIA SPA

Rectal/faecal specimen collection kit

• Primary Device ID: 38053326002206
• NIH Device Record Key: 97d7ce13-a1d1-47e1-bb3f-cfd6f15cc434
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FecalSwab®
• Version Model Number: 4C024S10
• Catalog Number: 4C024S10
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 10
• 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	18053326002202 [Unit of Use]
GS1	28053326002209 [Primary]
GS1	38053326002206 [Package]; Contains: 28053326002209; Package: [20 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: 2024-05-15
• Device Publish Date: 2024-05-07

Devices Manufactured by COPAN ITALIA SPA

• 58053326011684 - FLOQSwabs®: 2024-12-26 Specimen collection swab, regular, breaking point 80 mm, in tube
• 58053326011592 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL
• 58053326011608 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL + One regular flocked swab
• 58053326011615 - UTM®: 2024-11-21 Copan Universal Transport Medium (UTM-RT®) System 3 mL + One minitip flocked swab
• 58053326011509 - FLOQSwabs®: 2024-07-10 Specimen collection swab, regular, breaking point 60mm, in tube
• 58053326011523 - FLOQSwabs®: 2024-07-10 Specimen collection swab, regular, 60 mm breakpoint, in tube
• 28053326004524 - Sample Diluent Tube: 2024-05-15 1ML SAMPLE DILUENT TUBE IN BULK
• 38053326002206 - FecalSwab®: 2024-05-152 ml modified Cary Blair Orange Cap+Flocked Swab
• 38053326002206 - FecalSwab®: 2024-05-15 2 ml modified Cary Blair Orange Cap+Flocked Swab