Mswab® 07007248190

GUDID 58053326006192

MSwab Kit 1,6 mL Collection transport and preservation system for Gram positive aerobic & facultative anaerobic bacteria & HSV1/HSV2

COPAN ITALIA SPA

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

• Primary Device ID: 58053326006192
• NIH Device Record Key: 40f22dc1-3737-453f-8efb-e922e97b5d63
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mswab®
• Version Model Number: 07007248190
• Catalog Number: 07007248190
• 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	18053326006194 [Unit of Use]
GS1	38053326006198 [Primary]
GS1	58053326006192 [Package]; Contains: 38053326006198; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121039

FDA Product Code

• JTW: System, Transport, Aerobic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

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 [Mswab® ]

• 58053326006192: MSwab Kit 1,6 mL Collection transport and preservation system for Gram positive aerobic & facult
• 58053326006185: 1,6 mL of MSwab® medium + regular FLOQSwabs®