Bivona

Primary DI
15019517015348
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT15IN40NGC255N
Published
2019-02-22
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
15019517015348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951701534815019517015348

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
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
10887709194738BivonaFP26FN35NSA007N2026-06-02
10887709194745BivonaFT26FN35NGE008N2026-06-02
10887709194752BivonaHT26FS85NSC009N2026-06-02
10887709194769BivonaFT26FN40NGF012N2026-06-02
10887709194776BivonaFT26FN35NSE011N2026-06-02
10887709194783BivonaXT26FS50NSA010N2026-06-02
10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709194288BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194295BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194301BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194318BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194332BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194349BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194363BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194370BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194387BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194394BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194400BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194417BivonaICU MEDICAL, INC.JOH2026-06-01