FLOQSwabs ® 519CS01.VER

GUDID 18053326009577

Regular, Sterile Single Wrapped, Molded bp

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

• Primary Device ID: 18053326009577
• NIH Device Record Key: 3d86865d-a91f-4982-acfe-768e28bbf608
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLOQSwabs ®
• Version Model Number: 519CS01.VER
• Catalog Number: 519CS01.VER
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 1000
• 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	18053326009577 [Unit of Use]
GS1	58053326009575 [Primary]

FDA Product Code

• KXG: Applicator, Absorbent Tipped, Sterile

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: 2024-03-06
• Device Publish Date: 2024-02-27

Devices Manufactured by COPAN ITALIA SPA

• 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 ®: 2024-03-06Regular, Sterile Single Wrapped, Molded bp
• 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
• 38053326000721 - Inoculation Loops: 2024-01-25 HARD LOOP 1 µL STERILE, IN BAGS OF 20 PCS
• 38053326000738 - Inoculation Loops: 2024-01-25 HARD LOOP 10 µL STERILE, IN BAGS OF 20 PCS