Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression

Device Code: 1783

Product Code(s): FEF

Device Classification Information

• Device Type ID: 1783
• Device Name: Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
• Regulation Description: Gastrointestinal Tube And Accessories.
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD); Gastroenterology Devices Branch (GEDB)
• Submission Type: 510(k)
• CFR Regulation Number: 876.5980 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: FEF
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 5-109 ISO 80369-3 First Edition 2016-07-01
  Small-bore Connectors For Liquids And Gases In Healthcare Applications - Part 3: Connectors For Enteral Applications.
• 5-119 ISO 18250-3 First Edition 2018-06
  Medical Devices - Connectors For Reservoir Delivery Systems For Healthcare Applications - Part 3: Enteral Application
• 9-31 AAMI ANSI ID54:1996/(R)2012
  Enteral Feeding Set Adapters And Connectors
• 9-113 CEN EN 1618:1997
  Catheters Other Than Intravascular Catheters - Test Methods For Common Properties

Total Product Life Cycle

• Device Type ID: 1783
• Device: Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression
• Product Code: FEF
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Gastrointestinal Tube And Accessories.
• CFR Regulation Number: 876.5980 [🔎]

TPLC Last Update: 2019-04-02 19:59:33