AVANTGARDE

GUDID 15060182171891

Fecal Management System

PROSYS INTERNATIONAL LIMITED

Faecal incontinence kit

• Primary Device ID: 15060182171891
• NIH Device Record Key: 71ecf931-3919-4b88-bad5-6dc55eca3e1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AVANTGARDE
• Version Model Number: AVG100+T
• Company DUNS: 221836112
• Company Name: PROSYS INTERNATIONAL LIMITED
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• 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	05060182171894 [Primary]
GS1	15060182171891 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193325

FDA Product Code

• KNT: Tubes, Gastrointestinal (And Accessories)

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: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [AVANTGARDE]

• 15060182171556: Fecal Collection Bag
• 15060182171891: Fecal Management System