Bivona

Primary DI
10351688786579
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
ST14CN90NSC225N
Published
2015-08-31
Public version status
Update
Distribution status
Not 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
10351688786579PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168878657910351688786579

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
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197814BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197821BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197913BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197920BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197944BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197951BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197968BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197975BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197982BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197999BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198002BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198019BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198026BivonaICU MEDICAL, INC.JOH2026-07-10
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