BACK FLOW VALVE SINGLE USE PKG OF 10
N/A - 100126P
Device Description
A device intended to be fitted to an endoscope air/water channel to enable the operator to control inflow of medical gases [i.e., air, carbon dioxide (CO2)] for insufflation, and/or water for irrigation, whilst preventing backflow. It is in the form of an attachable inflow valve with closed and open settings. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: OCX
Device Name: Endoscopic Irrigation/Suction System
Device Class: 2
Physical State: may include: pump, motor, tubing, controller, air switch, power supply, transducer, digital display, suction attachment, bottle cap
Definition: To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.
Submission Type ID: 1
Review Panel: GU
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: Connects to tubing from pump and goes down working channel of endoscope
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: endoscope
Regulation Number: 876.1500
Third Party Flag: N
Medical Specialty: GU
Device Identifiers
Device Id: 04961333241712
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 14961333241719
Device Type: Unit of Use
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
