Bivona

Primary DI
10887709204604
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT26IN65NSD154N
Device description
FT26IN65NSD154N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-09-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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
10887709204604PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920460410887709204604

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, reinforced, non-customized, reusableAn armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
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
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
10887709204383BivonaICU MEDICAL, INC.JOH2026-09-18