Bivona

Primary DI
15019517039870
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SA16BN80NSC010N
Published
2016-02-03
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
15019517039870PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951703987015019517039870

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
10887709195131BivonaST26FN50NGF055N2026-06-08
10887709195148BivonaFT25LN30NGF157N2026-06-08
10887709195155BivonaFT26FN35NSF050N2026-06-08
10887709195162BivonaHT26FS45NGF051N2026-06-08
10887709195179BivonaFT26FN40NGF053N2026-06-08
10887709195186BivonaFT26FN35NGF054N2026-06-08
10887709195193BivonaFU26FN45NGF049N2026-06-08
10887709195209BivonaFT26FN60NGA046N2026-06-08
10887709195216BivonaFT26FN35NGE057N2026-06-08
10887709195223BivonaFT26FN30NGE056N2026-06-08
10887709195230BivonaFP26FN40NGC058N2026-06-08
10887709195247BivonaFT26FN35NSF059N2026-06-08
10887709195254BivonaFT26FN40NGE063N2026-06-08
10887709195261BivonaXT26FS60NGC064N2026-06-08
10887709195278BivonaFU26FN45NSF052N2026-06-08
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709195131BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195148BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195155BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195162BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195179BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195186BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195193BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195209BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195216BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195223BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195230BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195247BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195254BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195261BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195278BivonaICU MEDICAL, INC.JOH2026-06-08
10887709194967BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194974BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194981BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194998BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195001BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195018BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195025BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195032BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195049BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195056BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195063BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195070BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195087BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195094BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195100BivonaICU MEDICAL, INC.JOH2026-06-05