Sputum Dipper 2U063S01

GUDID 38053326005016

Transfer device sterile individually wrapped for SL solution

COPAN ITALIA SPA

Specimen transfer scooping tool IVD

• Primary Device ID: 38053326005016
• NIH Device Record Key: 361b9453-3d39-4ab8-9a59-b598b5bfac3f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sputum Dipper
• Version Model Number: 2U063S01
• Catalog Number: 2U063S01
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 100
• 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	18053326005012 [Unit of Use]
GS1	28053326005019 [Primary]
GS1	38053326005016 [Package]; Contains: 28053326005019; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• LXG: Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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: 2024-01-25
• Device Publish Date: 2024-01-17

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®: 2024-05-15 2 ml modified Cary Blair Orange Cap+Flocked Swab