ZUTRON AUTO LEAK TESTER POWER SUPPLY
ZUTRON - ZUTRT1079P5PND
Device Description
An insulated electrical cord designed with a mains electricity supply plug at one end and single or multiple outlet socket clusters at the other end, intended to enable a connection between a medical device and a mains electricity supply. It is typically used where there is a need for many electrically-powered medical devices, e.g., in the operating room (OR). It is manufactured to medical grade standards for use in healthcare facilities and the home, providing the required legislative level of electrical safety; it may include an adaptor/transformer. 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 IdentifiersDevice Id: 04961333244515
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