Product Overview

Overpressure Safety Valve - LH130


Device Description

A sterile, mechanical regulator used in a cardiopulmonary bypass system, particularly systems employing centrifugal pumps during open-heart surgery. It typically provides unidirectional flow to prevent inadvertent backflow of blood and air into the heart, and/or controls the pressure within the system (e.g., maintains gentle suction to prevent line collapse during left ventricular venting, or controls the vacuum from suctioning of the heart or the surgical field). This is a single-use device.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: DTL

Device Name: Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 4

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: 870.4290

Third Party Flag: N

Medical Specialty: CV


Device Identifiers

Device Id: 50699753450221

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 00699753450226

Package Quantity: 25

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: 25 Piece Case


Device Id: 00699753450226

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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