Bivona

Primary DI
15021312006797
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
850180
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
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
K083641000
K913859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K913859000BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATIONBivona Medical Technologies1992-01-30JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312006797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131200679715021312006797

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
10887709204826BivonaFT26IN35NSA181N2026-09-24
10887709204833BivonaFT26IN40NGE170N2026-09-24
10887709204840BivonaFT26IN45NGF169N2026-09-24
10887709204857BivonaFT26IN40NGE179N2026-09-24
10887709204864BivonaFT26IN40NGF172N2026-09-24
10887709204871BivonaFT26IN55NGF171N2026-09-24
10887709204888BivonaHU26IS40NGE177N2026-09-24
10887709204895BivonaHU26IS45NGF178N2026-09-24
10887709204505BivonaFU26IN40NGF143N2026-09-22
10887709204512BivonaFU26IN35NGF144N2026-09-22
10887709204550BivonaFU26IN60NSF145N2026-09-22
10887709204680BivonaFU26IN55NSA164N2026-09-22
10887709204697BivonaFU26IN40NGF160N2026-09-22
10887709204703BivonaFT26IN40NGF162N2026-09-22
10887709204710BivonaFT26IN35NGF161N2026-09-22
10887709204727BivonaFT26IN40NGE166N2026-09-22
10887709204741BivonaFT26IN40NGF160N2026-09-22
10887709204475BivonaHU26IS45NGG042N2026-09-21
10887709204482BivonaSU26IN45NGF043N2026-09-21
10887709204574BivonaSF26IN70SSC152N2026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709204826BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204833BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204840BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204857BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204864BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204871BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204888BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204895BivonaICU MEDICAL, INC.JOH2026-09-24
10887709204505BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204512BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204550BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204680BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204697BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204703BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204710BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204727BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204741BivonaICU MEDICAL, INC.JOH2026-09-22
10887709204475BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204482BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204574BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204581BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204598BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204604BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204611BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204635BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204642BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204659BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204666BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204673BivonaICU MEDICAL, INC.JOH2026-09-21
10887709204499BivonaICU MEDICAL, INC.JOH2026-09-20