Product Classification

• Device: balloon, liver tamponade
• Regulation Description: Gastrointestinal tube and accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: General & Plastic Surgery
• Product Code: NGU
• Submission Type: 510(k)
• Regulation Number: 876.5980
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standard

• AAMI/ANSI ID54:1996/(R)2005 Enteral feeding set adapters and connectors

Third Party Review

• Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

• dekra certification b.v.
• intertek testing services
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.