CultureSwab™ MaxV(+) 220236

GUDID 58053326002071

MaxV(+) CULTURE SWAB MAXV(+) DUAL AMIES W/O CH TWO PLASTIC RAYON Amies Gel w/o Charcoal Double 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

• Primary Device ID: 58053326002071
• NIH Device Record Key: 26605abd-ee06-4ee4-9296-27f9591f715b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CultureSwab™ MaxV(+)
• Version Model Number: 220236
• Catalog Number: 220236
• 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	18053326002073 [Unit of Use]
GS1	38053326002077 [Primary]
GS1	58053326002071 [Package]; Contains: 38053326002077; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972448

FDA Product Code

• JSL: Culture Media, Anaerobic 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: 2023-06-22
• Device Publish Date: 2023-06-14

On-Brand Devices [ CultureSwab™ MaxV(+)]

• 58053326002064: CultureSwab™ MaxV(+) Amies Gel w/o Charcoal Single Plastic Applicators
• 58053326002071: MaxV(+) CULTURE SWAB MAXV(+) DUAL AMIES W/O CH TWO PLASTIC RAYON Amies Gel w/o Charcoal Double