CultureSwab™ MaxV(+) 220235

GUDID 58053326002064

CultureSwab™ MaxV(+) Amies Gel w/o Charcoal Single Plastic Applicators

COPAN ITALIA SPA

General specimen collection kit

• Primary Device ID: 58053326002064
• NIH Device Record Key: 4c7ebcae-797a-4519-a514-5e95d4a0dd78
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CultureSwab™ MaxV(+)
• Version Model Number: 220235
• Catalog Number: 220235
• 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	18053326002066 [Unit of Use]
GS1	38053326002060 [Primary]
GS1	58053326002064 [Package]; Contains: 38053326002060; 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: 2022-12-15
• Device Publish Date: 2022-12-07

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