Medex

Medex - 292004

A manually-powered device designed to instill air into the cuff of an in situ endotracheal (ET)/endobronchial tube. The inflator typically includes a manually-operated rubber bulb for the delivery of ambient air into the cuff, and a pressure gauge or manometer that displays the pressure within the cuff to help prevent the development of excessive pressure which may cause trauma to the trachea. The purpose of the cuff is to provide an adequate seal for positive pressure ventilation and to prevent aspirated secretions from passing into the lungs. This is a reusable device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: BSK

Device Name: Cuff, Tracheal Tube, Inflatable

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: Y

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 868.5750

Third Party Flag: Y

Medical Specialty: AN

Device Id: 50351688517171

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10351688517173

Package Quantity: 10

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10351688517173

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