Bivona

Basic Information

• Brand Name: Bivona
• Primary DI: 35021312009822
• Version / Model: BV0936
• 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: f2a7cd92-8726-4377-b85a-23d773b78f0e

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 Safe
• 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
BTO	Tube, tracheostomy (w/wo connector)	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
14093	Tracheostoma button	A hollow device intended to be used routinely by a patient to prevent the narrowing of a tracheostoma during intermittent use of their tracheostomy or laryngectomy tube. It is a cylindrical synthetic polymer device designed for minimal intrusion beyond the tracheostomal orifice into which it is placed. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	35021312009822	GS1

Premarket Submissions

Submission Number	Supplement Number
K810436	000