BHI BROTH 474CE.A

GUDID 28053326001028

BHI BROTH FOR AUTOMATION

COPAN ITALIA SPA

General specimen container IVD, additive/medium

• Primary Device ID: 28053326001028
• NIH Device Record Key: 4962f56c-871e-4d9b-935d-70d23051570c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BHI BROTH
• Version Model Number: 474CE.A
• Catalog Number: 474CE.A
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: true
• 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	08053326001024 [Unit of Use]
GS1	18053326001021 [Primary]
GS1	28053326001028 [Package]; Contains: 18053326001021; Package: [6 Units]; In Commercial Distribution

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: 2023-03-13
• Device Publish Date: 2023-03-03

Devices Manufactured by COPAN ITALIA SPA

• 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
• 58053326011073 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One minitip flocked swab, breaking point 80 mm