ACCSY 150075 PULM WEDGE PRESS MONITOR5PK
Pulmonary Wedge Pressure Catheter - 150075
Device Description
A flexible, non-electrical tube with an inflatable balloon at its distal tip designed to be introduced percutaneously into the venous system via a central vein (e.g., jugular, subclavian), and advanced from the superior vena cava to the pulmonary artery, to measure/monitor a haematological parameter(s) [e.g., pulmonary arterial pressures (e.g., wedge), stroke volume] via the pressure changes at its distal tip. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., external blood pressure transducer) and may include devices dedicated to introduction. This is a single-use device.
Environmental Conditions
- Storage - in a cool, dry, dark place with protective sheaths fitted over balloons as protection against the atmosphere and fluorescent, ultraviolet and/or incandescent light.
Device Sizes
- Length: 110.0 Centimeter
- Catheter Gauge: 7.0 French
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: DQO
Device Name: Catheter, Intravascular, Diagnostic
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: CV
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 870.1200
Third Party Flag: Y
Medical Specialty: CV
Device IdentifiersDevice Id: 20613994733652
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 00613994733658
Package Quantity: 5
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: PK
Device Id: 00613994733658
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