Bivona

Primary DI
15019517227536
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XU20ES60NGF997N
Published
2020-05-04
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
15019517227536PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951722753615019517227536

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
10887709198385BivonaXZ26GS70NSC058N2026-08-03
10887709198866BivonaFU26GN40NSZ134N2026-08-03
10887709198880BivonaXU26GS55NGZ141N2026-08-03
10887709199368BivonaZT26GN95ZSZ155N2026-08-03
10887709199580BivonaFT26GN45NSE190N2026-08-03
10887709199641BivonaSA26GN80ZSZ135N2026-08-03
10887709199764BivonaXU26GS60NSA218N2026-08-03
10887709199771BivonaFU26GN55NSF216N2026-08-03
10887709199788BivonaXU26GS60NSA217N2026-08-03
10887709199801BivonaFU25GN65NSD167N2026-08-03
10887709199818BivonaSU26GN50NGF219N2026-08-03
10887709199825BivonaFU26GN45NSC211N2026-08-03
10887709199832BivonaFU26GN45NGF214N2026-08-03
10887709199849BivonaFU26GN35NSE226N2026-08-03
10887709199856BivonaFU26GN30NSE227N2026-08-03
10887709199863BivonaFT26GN40NSC233N2026-08-03
10887709200002BivonaFU26GN45NSF240N2026-08-03
10887709200019BivonaFT26GN55NGF246N2026-08-03
10887709200026BivonaFU26GN30NGA239N2026-08-03
10887709200033BivonaST26GN55NSC245N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709198385BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198866BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198880BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199368BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199580BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199641BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199764BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199771BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199788BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199801BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199818BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199825BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199832BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199849BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199856BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199863BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200002BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200019BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200026BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200033BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200149BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200163BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200170BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200187BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200194BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200200BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200217BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200224BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200231BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200248BivonaICU MEDICAL, INC.JOH2026-08-03