Bivona

Primary DI
10351688834652
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU14KN35NGE200N
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K923878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923878000BIVONA CUSTOMIZED TRACHEOSTOMY TUBESBivona Medical Technologies1992-12-29JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688834652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168883465210351688834652

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, reusableA 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 custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709199061BivonaFT26GN50NGF159N2026-07-22
10887709198095BivonaFT26GN40NGF059N2026-07-21
10887709198521BivonaST26GN65NSC093N2026-07-21
10887709198897BivonaHT26GS50NSC139N2026-07-21
10887709198903BivonaHU26GS50NSC140N2026-07-21
10887709198910BivonaFU26GN45NSF142N2026-07-21
10887709198927BivonaFT26GN60NSF137N2026-07-21
10887709198934BivonaFT26GN70NSC136N2026-07-21
10887709198965BivonaXT26GS60NGF149N2026-07-21
10887709198972BivonaFT26GN40NSF150N2026-07-21
10887709198996BivonaFU26GN40NSF151N2026-07-21
10887709199009BivonaFT26GN45NSF147N2026-07-21
10887709199016BivonaFU26GN50NSF146N2026-07-21
10887709199023BivonaFU26GN45NGF148N2026-07-21
10887709199030BivonaFU26GN30NGE153N2026-07-21
10887709199047BivonaFU26GN35NGE152N2026-07-21
10887709199054BivonaXU26GS45NGF154N2026-07-21
10887709198491BivonaSU26EN50NGF192S2026-07-20
10887709198507BivonaSU26GN40NGF092N2026-07-20
10887709198514BivonaFT26GN60NSC091N2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709199061BivonaICU MEDICAL, INC.JOH2026-07-22
10887709198095BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198521BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198897BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198903BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198910BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198927BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198934BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198965BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198972BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198996BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199009BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199016BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199023BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199030BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199047BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199054BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198491BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198507BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198514BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198538BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198545BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198552BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198576BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198583BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198590BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198606BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198613BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198620BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198767BivonaICU MEDICAL, INC.JOH2026-07-20