LIM Broth 476CE.A

GUDID 28053326000342

TODD HEWITT WITH CNA BROTH FOR AUTOMATION

COPAN ITALIA SPA

General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium General specimen container IVD, additive/medium

• Primary Device ID: 28053326000342
• NIH Device Record Key: 8c6f3d3a-84e6-4dd3-b4b7-0f35849ca7c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LIM Broth
• Version Model Number: 476CE.A
• Catalog Number: 476CE.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	08053326000348 [Unit of Use]
GS1	18053326000345 [Primary]
GS1	28053326000342 [Package]; Contains: 18053326000345; 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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by COPAN ITALIA SPA

• 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®: 2024-05-15 2 ml modified Cary Blair Orange Cap+Flocked Swab
• 58053326005591 - CLASSIQSwabs™: 2024-05-07 Sterile Plastic Applicator Poliester Tipped Individually Wrapped
• 58053326005690 - CLASSIQSwabs™: 2024-05-07 Sterile Plastic Applicator Rayon Tipped Individually Wrapped
• 58053326009797 - CLASSIQSwabs™: 2024-05-07 Regular Polyester Swab, breaking point 100mm
• 18053326009577 - FLOQSwabs ®: 2024-03-06 Regular, Sterile Single Wrapped, Molded bp