Bivona

Bivona - SAT605

A sterile, hollow, cylindrical, curved device designed as an internal, independent component of a metal or plastic tracheostomy tube. It is made of plastic and has precise dimensions allowing it to fit exactly into the outer tube and function as the inner cannula for tracheostomy tubes that have this kind of function. It is removed once or more times daily to facilitate the removal of phlegm, slime, and contamination build-up, thereby preventing blockage and infection of the stoma and eliminates the traumatic removal of the tracheostomy tube. This is a single-use device.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: True

Sterilization Methods:

• Moist Heat or Steam Sterilization

Code: BTR

Device Name: Tube, Tracheal (W/Wo Connector)

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: 868.5730

Third Party Flag: N

Medical Specialty: AN

Device Id: 35021312010903

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