BBL™ CultureSwab™ EZ II 220145

GUDID 58053326002156

BBL™ CultureSwab™ EZ II CultureSwab EZ Swab Double

COPAN ITALIA SPA

General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 58053326002156
• NIH Device Record Key: 3ddf1bee-ed5a-4dfc-925f-2b56ce53ed6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBL™ CultureSwab™ EZ II
• Version Model Number: 220145
• Catalog Number: 220145
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 100
• 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	18053326002158 [Unit of Use]
GS1	38053326002152 [Primary]
GS1	58053326002156 [Package]; Contains: 38053326002152; Package: [6 Units]; In Commercial Distribution

FDA Product Code

• JTW: System, Transport, Aerobic

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: 2022-12-15
• Device Publish Date: 2022-12-07

Devices Manufactured by COPAN ITALIA SPA

• 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
• 38053326000653 - Inoculation Loops: 2024-01-25 SOFT LOOP 10 UL STERILE, IN BAG OF 10 PCS
• 38053326000660 - Inoculation Loops: 2024-01-25 SOFT LOOP 10 µL STERILE, IN BAG OF 20 PCS