CultureSwab™ MaxV 220233

GUDID 58053326002040

LQ Stuart Single Plastic Applicators

COPAN ITALIA SPA

General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit General specimen collection kit

• Primary Device ID: 58053326002040
• NIH Device Record Key: 72356a43-a41a-40ba-be28-286ff8a549ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CultureSwab™ MaxV
• Version Model Number: 220233
• Catalog Number: 220233
• 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	18053326002042 [Unit of Use]
GS1	38053326002046 [Primary]
GS1	58053326002040 [Package]; Contains: 38053326002046; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K946283

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2023-03-13
• Device Publish Date: 2023-03-03

On-Brand Devices [ CultureSwab™ MaxV]

• 58053326002057: CultureSwab™ MaxV CultureSwab Max V LQ Stuart Double Plastic Applicators
• 58053326002033: CultureSwab™ MaxV CultureSwab Max V LQ Amies Double Plastic Applicators
• 58053326002040: LQ Stuart Single Plastic Applicators
• 58053326002026: LQ Amies Single Plastic Applicators