eSwab™ 4C012S.A

GUDID 38053326000233

Eswab autom. Round tube LQ Amies Regular Nylon Flocked Applicator

COPAN ITALIA SPA

General specimen collection kit

• Primary Device ID: 38053326000233
• NIH Device Record Key: 56b1bc40-53f1-4813-813e-f23a942288e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eSwab™
• Version Model Number: 4C012S.A
• Catalog Number: 4C012S.A
• Company DUNS: 428981112
• Company Name: COPAN ITALIA SPA
• Device Count: 50
• 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	18053326000239 [Unit of Use]
GS1	28053326000236 [Primary]
GS1	38053326000233 [Package]; Contains: 28053326000236; Package: [10 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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [eSwab™ ]

• 58053326005379: 1 LQ AMIES TEST TUBE+2 PINK APPLICATORS+1 WHITE APPLICATOR
• 58053326005362: 1 LQ AMIES TEST TUBE + 1 PINK APPLICATORS + 1 WHITE APPLICATOR
• 58053326002187: ESwab™ Collection Kit Flexible mini-tip
• 58053326002170: ESwab™ Collection Kit Mini-tip
• 58053326002163: ESwab™ Collection Kit Regular
• 58053326000053: ESWAB LQ AMIES REG.FLOCK DOUBLE WRAPPED
• 38053326002640: ESWAB LQ AMIES, NON CAPTURE PURPLE CAP, REG. NYLON FLOCKED APPLICATOR
• 38053326000196: ESWAB LQ AMIES REG. NYLON FLOCKED APPLICATOR
• 38053326000165: ESWAB LQ AMIES PERNASAL NYLON FLOCKED APPLICATOR
• 38053326000141: ESWAB LQ AMIES MINITIP NYLON FLOCKED APPLICATOR
• 38053326000028: ESWAB PINK CAP LQ AMIES REG. NYLON FLOCKED APPLICATOR
• 58053326000015: LQ AMIES REG.FLOCKED+RAYON PL.APPLICATOR
• 68053326009527: ESWAB LQ AMIES 2 mL REG. NYLON FLOCKED APPLICATOR
• 38053326000233: Eswab autom. Round tube LQ Amies Regular Nylon Flocked Applicator