Bivona

Primary DI
10351688717436
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT13BN40NGE239N
Published
2015-09-30
Public version status
Update
Distribution status
Not 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
10351688717436PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168871743610351688717436

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
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14
10887709198286BivonaFT26GN35NGE081N2026-07-14
10887709198293BivonaHT26GS60NSC086N2026-07-14
10887709198309BivonaFT26GN40NGE082N2026-07-14
10887709198316BivonaFT26GN30NSE087N2026-07-14
10887709198323BivonaFT26GN35NSE088N2026-07-14
10887709198330BivonaFT26GN55NSF084N2026-07-14
10887709198033BivonaFT26GN40NGE057N2026-07-13
10887709198040BivonaXA26GS70NSC058N2026-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709198163BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198170BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198187BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198194BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198200BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198217BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198224BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198231BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198248BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198255BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198262BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198279BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198286BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198293BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198309BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198316BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198323BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198330BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198033BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198040BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198057BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198071BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198088BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198125BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198132BivonaICU MEDICAL, INC.JOH2026-07-13
10887709197814BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197821BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197913BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197920BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197944BivonaICU MEDICAL, INC.JOH2026-07-10