AUTOMATED ENDOSCOPE LEAK TESTER

AUTOMATED ENDOSCOPE LEAK TESTER - ALT-Pro

An electrically-powered device intended to test an invasive medical device (e.g., flexible endoscope, ultrasound transducer) for leaks of air and/or fluid from its internal channels and/or housing by introducing air at increased pressures. It typically incorporates an electric pump with a manometer and controls intended to be connected to the device tested. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PCV

Device Name: Endoscopic Leak Tester

Device Class: 2

Physical State: Leak detection apparatus

Definition: An endoscopic leak tester automatically detects leaks from endoscopes, without requiring visual observation for bubbles when the device is immersed in water, by assessing differences in air pressure inside the pressurized endoscope.

Submission Type ID: 1

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The device automatically detects leaks.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Flexible endoscopes.

Regulation Number: 876.1500

Third Party Flag: N

Medical Specialty: GU

Device Id: 04953170415180

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