UTM® 3C099N01

GUDID 58053326011608

Copan Universal Transport Medium (UTM-RT®) System 3 mL + One regular flocked swab

COPAN ITALIA SPA

General specimen collection kit

• Primary Device ID: 58053326011608
• NIH Device Record Key: 414783b5-9f9e-4980-a3ed-5bedc452d101
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: UTM®
• Version Model Number: 3C099N01
• Catalog Number: 3C099N01
• 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	18053326011600 [Unit of Use]
GS1	38053326011604 [Primary]
GS1	58053326011608 [Package]; Contains: 38053326011604; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K232357

FDA Product Code

• JSM: Culture Media, Non-Propagating Transport

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: 2024-11-21
• Device Publish Date: 2024-11-13

On-Brand Devices [UTM® ]

• 38053326002916: Medium + Minitip sterile Flocked Swab
• 38053326002893: Medium + Regular sterile Flocked Swab
• 38053326000707: Medium + Pernasal sterile Flocked Swab
• 38053326000509: MINI UTM KIT 1 mL Medium + Pernasal sterile Flocked Swab
• 28053326002988: UTM 10mL Tube in bulk
• 28053326001417: UTM 3 mL Tube in bulk
• 38053326001438: MINI UTM KIT 3 mL Medium + Regular sterile Flocked Swab
• 38053326001421: UTM KIT 3 mL Medium + Regular sterile Flocked Swab
• 28053326000496: UTM MINI 3 Ml Tube in bulk
• 28053326000489: UTM MINI 1 mL Tube in bulk
• 38053326003166: MINI UTM KIT 1 mL Medium + Minitip sterile Flocked Swab
• 38053326003159: MINI UTM KIT 1 mL Medium + Regular sterile Flocked Swab
• 18053326002837: UTM KIT 3 mL Medium + 2 Regular Polyester sterile Swabs
• 38053326002831: UTM KIT 3 mL Medium + 2 Regular Polyester sterile Swabs
• 58053326011615: Copan Universal Transport Medium (UTM-RT®) System 3 mL + One minitip flocked swab
• 58053326011608: Copan Universal Transport Medium (UTM-RT®) System 3 mL + One regular flocked swab
• 58053326011592: Copan Universal Transport Medium (UTM-RT®) System 3 mL