WATER CONTAINER - MAJ-901
Device Description
A device intended to be used during endoscopy procedures to provide a receptacle for irrigation water and a conduit for air/carbon dioxide (CO2) used for insufflation. It is typically in the form of an empty plastic bottle with a connector intended to attach to the proximal end of an endoscope and/or to a gas supply. This is a reusable device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: True
Sterilization Methods:
- High-level Disinfectant
- Moist Heat or Steam Sterilization
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: 04953170465949
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
