Bivona

Bivona - SU20BN45NSC044S

A custom-made, hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not reinforced with a wire. It is constructed with specific characteristics (e.g., size, shape, material) as prescribed by a healthcare provider for a specific patient. It may be constructed of metal or plastic, might include an inner cannula and may be one of a variety of designs (e.g., cuffed, uncuffed, and/or fenestrated). It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.

No Data Available

No Data Available

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: JOH

Device Name: Tube Tracheostomy And Tube Cuff

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: 868.5800

Third Party Flag: Y

Medical Specialty: AN

Device Id: 15019517220728

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