LBM® TSB Salt 477CE.A

GUDID 28053326002247

TSB SALT BROTH X AUTOMATION

COPAN ITALIA SPA

General specimen container IVD, additive/medium

• Primary Device ID: 28053326002247
• NIH Device Record Key: 070b8cc6-67f5-49ed-bc5f-46dd0c59a520
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LBM® TSB Salt
• Version Model Number: 477CE.A
• Catalog Number: 477CE.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	08053326002243 [Unit of Use]
GS1	18053326002240 [Primary]
GS1	28053326002247 [Package]; Contains: 18053326002240; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• JSD: Culture Media, Selective Broth

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: 2023-06-22
• Device Publish Date: 2023-06-14

Devices Manufactured by COPAN ITALIA SPA

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• 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
• 58053326011189 - 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
• 18053326010405 - Copan Universal Transport Medium (UTM-RT) System: 2025-06-05 Copan Universal Transport Medium (UTM-RT) System 3ml + One progressive flocked swab, breaking point 80 mm
• 58053326011714 - UriSponge™: 2025-03-20 UriSponge™ - Urine Collection, Transport, and Preservation System 100mm lenght x 16mm diameter