Product Overview

N/A - 100110P

Device Description

A sterile, hand-operated surgical device intended for the controlled delivery of medical gas and fluid (e.g., saline solution) to an open surgical site to improve visibility, by clearing bloody fluids/debris, and to prevent tissue desiccation. It is typically made of plastic materials [e.g., polypropylene, polyvinyl chloride (PVC)] and may be double-lumen for nebulization of fluid/gas, or dual-line for separate fluid and gas administration and include an antibacterial filter. It typically includes a nozzle at the distal end and connector(s) [e.g., Luer] at the proximal end for connection to the fluid/gas sources; a manual tubing clamp may also be included. 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: 04961333241699

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

Educational Resources