ProTube

GUDID 07640172343005

The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collection phase is carried out safely and in a traceable way. The ProTube System is designed to support positive patient identification, order review, automatic tube recognition, automatic tube labelling, production of single labels for biological sample containers and sample check-out.

Inpeco SA

Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD Specimen information management system IVD

• Primary Device ID: 07640172343005
• NIH Device Record Key: e40cc2db-0b0c-4568-9b68-1ef6271706b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProTube
• Version Model Number: PTB
• Company DUNS: 484880690
• Company Name: Inpeco SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640172343005 [Primary]

FDA Product Code

• JQP: Calculator/Data Processing Module, For Clinical Use

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: 2020-09-21
• Device Publish Date: 2020-09-11

On-Brand Devices [ProTube]

• 07640172343005: The ProTube System is designed to automate biological sample collection process. ProTube ensures
• 07640172343012: ProTube is designed to automate biological sample collection process. ProTube ensures the biolog