Bivona

Basic Information

• Brand Name: Bivona
• Primary DI: 10887709162263
• Version / Model: FT25FN35NSF246N
• Company Name: ICU MEDICAL, INC.
• Labeler DUNS: 118380146
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-06-27
• Public Version: 2
• Public Version Date: 2025-07-17
• Public Version Status: Update
• Public Device Record Key: 5080e343-6d56-4195-a5fa-e10a0a91f9b3
• Distribution End Date: 2025-07-16

Device Description

FT25FN35NSF246N Bivona DI: Non-Adjustable-Wired_Non-Sterile

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: No
• Has Expiration Date: No
• 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
JOH	Tube tracheostomy and tube cuff	Anesthesiology	868.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
63798	Tracheostomy tube, reinforced, non-customized, reusable	An armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. 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	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10887709162263	GS1

Premarket Submissions

Submission Number	Supplement Number
K923878	000