Bivona

Primary DI
15019517014372
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT15HN35NSC165N
Published
2015-10-16
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
15019517014372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951701437215019517014372

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, 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 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 (however is not custom-made for a specific patient). 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
10887709194585BivonaFU26EN60NGA202S2026-06-03
10887709194615BivonaFT26EN50NGA210N2026-06-03
10887709194790BivonaFT26FN35NGE013N2026-06-03
10887709194806BivonaFT26FN35NGF014N2026-06-03
10887709194813BivonaHU26FS50NGF016N2026-06-03
10887709194820BivonaFT26FN45NSA017N2026-06-03
10887709194837BivonaFT26FN30NSF018N2026-06-03
10887709194844BivonaFT26FN35NGE020N2026-06-03
10887709194851BivonaFT26FN30NSE021N2026-06-03
10887709194868BivonaSU26FN50NGF022N2026-06-03
10887709194875BivonaFT26FN35NSF023N2026-06-03
10887709194882BivonaHU26FS45NSB015N2026-06-03
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194691BivonaST26EN55NTB208N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194585BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194615BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194790BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194806BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194813BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194820BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194837BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194844BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194851BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194868BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194875BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194882BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194660BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194677BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194684BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194691BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194707BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194714BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194721BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194738BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194745BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194752BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194769BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194776BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194783BivonaICU MEDICAL, INC.JOH2026-06-02
10887709193830BivonaICU MEDICAL, INC.JOH2026-06-01
10887709193847BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194257BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194264BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194271BivonaICU MEDICAL, INC.JOH2026-06-01