Bivona

Primary DI
15019517015126
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
ST15IN45NGF241N
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
15019517015126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951701512615019517015126

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
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197265BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197289BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197838BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197845BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197852BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197869BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197876BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197883BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197890BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197906BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197135BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197142BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197203BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197210BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197227BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197234BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197241BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197722BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197739BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197746BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197753BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197760BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197777BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197784BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197791BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197807BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197586BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197593BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197609BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197616BivonaICU MEDICAL, INC.JOH2026-07-07