Bivona

Primary DI
10351688811769
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XU13BS45NSA100N
Published
2015-08-31
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
10351688811769PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168881176910351688811769

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, 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 not custom-made for a specific patient and is not reinforced with a wire. 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. 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
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709194998BivonaXU26FS35NGA037N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05
10887709195018BivonaXU26FS35NGA039N2026-06-05
10887709195025BivonaXU26FS55NGC029N2026-06-05
10887709195032BivonaFT26FN45NSF030N2026-06-05
10887709195049BivonaFU26FN60NSA032N2026-06-05
10887709195056BivonaFT26FN25NGE033N2026-06-05
10887709195063BivonaFT26FN30NGE034N2026-06-05
10887709195070BivonaHT26FS70NSC042N2026-06-05
10887709195087BivonaSU26FN35NGF041N2026-06-05
10887709195094BivonaFT26FN30NGF045N2026-06-05
10887709195100BivonaFT26FN25NGF044N2026-06-05
10887709195117BivonaFA26FN70NSC047N2026-06-05
10887709195124BivonaFU26FN70NTC048N2026-06-05
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709195117BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195124BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194899BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194905BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194912BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194929BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194936BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194943BivonaICU MEDICAL, INC.JOH2026-06-04
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