FDA.reportPublic FDA data

Bivona

Primary DI
15021312005691
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
60N030
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTOTube, tracheostomy (w/wo connector)
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083641000
K912469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K912469000BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies1991-06-19BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312005691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131200569115021312005691

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197395BivonaFU26FN35NGE250N2026-07-06
10887709197401BivonaFU26FN30NGE251N2026-07-06
10887709197418BivonaSU26FN80NSC252N2026-07-06
10887709197425BivonaFT26FN45NGC256N2026-07-06
10887709197432BivonaFU26FN50NGC254N2026-07-06
10887709197449BivonaFT26FN50NGC255N2026-07-06
10887709197456BivonaFT26GN35NGE001N2026-07-06
10887709197463BivonaFT26GN40NGE002N2026-07-06
10887709197470BivonaFT26GN35NSA003N2026-07-06
10887709197487BivonaFU26GN40NSF004N2026-07-06
10887709197494BivonaXA26GS60NSC005N2026-07-06
10887709197500BivonaSA26GN60NSC006N2026-07-06
10887709197517BivonaSA26GN60NSC007N2026-07-06
10887709197524BivonaSA26GN60NSC008N2026-07-06
10887709197531BivonaSA26GN60NSC009N2026-07-06
10887709197548BivonaST26GN60NSC010N2026-07-06
10887709197555BivonaFU26GN50NSF011N2026-07-06
10887709197562BivonaFU26GN50NSF012N2026-07-06
10887709197579BivonaFT26GN35NGF013N2026-07-06
15019517382860ICU Medical, Inc.011-100/892/200CZ2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197395BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197401BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197418BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197425BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197432BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197449BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197456BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197463BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197470BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197487BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197494BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197500BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197517BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197524BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197531BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197548BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197555BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197562BivonaICU MEDICAL, INC.JOH2026-07-06
10887709197579BivonaICU MEDICAL, INC.JOH2026-07-06
15019517382860ICU Medical, Inc.ICU MEDICAL, INC.BTO2026-07-06
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00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09