Bivona

Basic Information

• Brand Name: Bivona
• Primary DI: 35021312010927
• Version / Model: SAT757
• Company Name: SMITHS MEDICAL ASD, INC.
• Labeler DUNS: 118112924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-01
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e6817804-5585-478f-b11a-ad1ee05bf4a5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14089	Tracheostomy tube cannula, single-use	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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	35021312010927	GS1

Premarket Submissions

Submission Number	Supplement Number
K915799	000