Bivona

Primary DI
15019517329995
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT23AN40NGA096N
Published
2024-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
15019517329995PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951732999515019517329995

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, reinforced, non-customized, reusableAn armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.

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