- Physicians Office Resource

Bard® Syringe Assist Irrigation System
Bard® Syringe Assist Irrigation System - 160130

Device Description

A general-purpose device used primarily for the flushing of body orifices with an irrigating solution. It may be designed with (e.g., a rigid plastic barrel with a fitted rubber bulb at one end and a nozzle at the other). 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: 10801741045759

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00801741045752

Package Quantity: 12

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: CA

Device Id: 00801741045752

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

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