LBM® UriSponge™ 8C023S01.A

GUDID 28053326003749

UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in single pouch

COPAN ITALIA SPA

Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative Non-evacuated urine specimen container IVD, preservative

• Primary Device ID: 28053326003749
• NIH Device Record Key: 28006d68-8b4e-4a08-ae29-389e656eef81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LBM® UriSponge™
• Version Model Number: 8C023S01.A
• Catalog Number: 8C023S01.A
• 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	08053326003745 [Unit of Use]
GS1	18053326003742 [Primary]
GS1	28053326003749 [Package]; Contains: 18053326003742; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180052

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [LBM® UriSponge™]

• 28053326003749: UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in single pouc
• 28053326003732: UriSponge™ – Urine Collection, Transport and Preservation System Regular size - in single po
• 28053326003725: UriSponge™ – Urine Collection, Transport and Preservation System Mini size - in bulk
• 28053326003718: UriSponge™ – Urine Collection, Transport and Preservation System Regular size - in bulk