- Physicians Office Resource

ZUTRON AUTOMATIC LEAK TESTER C
ZUTRON - ZUTR10003TG

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: FCY

Device Name: Bulb, Inflation, For Endoscope

Device Class: 1

Physical State: N/A

Definition: An endoscope bulb pressurizes the interior of an endoscope. The user identifies the presence of leaks in the endoscope by immersing in water and visually observing for bubbles.

Submission Type ID: 4

Review Panel: GU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: The user may select and maintain the pressure, or the device may control and maintain the selected pressure.

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: 04961333244492

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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