AUTOMATED ENDOSCOPE LEAK TESTER - ALT-Pro
Device Description
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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
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 Identifiers
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
