- Physicians Office Resource

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

Special Storage Condition, Specify

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

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 Identifiers

Device 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

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