Bivona

Primary DI
10887709194172
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT26EN40NGF176N
Device description
FT26EN40NGF176N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-05-22
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
10887709194172PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919417210887709194172

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
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709188720BivonaAT26CS50NSA182N2026-03-24
10887709188737BivonaAT26CS40NSA180N2026-03-24
10887709188744BivonaAT26CS40NSA181N2026-03-24
10887709188751BivonaAT26CS50NSA183N2026-03-24
10887709188836BivonaSU26CN45NGF194N2026-03-24
10887709188843BivonaSU26CN50NGF193N2026-03-24
10887709188850BivonaFT26CN65NSC192N2026-03-24
10887709188874BivonaFT26CN40NGE196N2026-03-24
10887709188881BivonaFT26CN50NSA199N2026-03-24
10887709188904BivonaHF26CS80NSC198N2026-03-24
10887709188805BivonaSU26CN55NGF1902026-03-23
10887709188812BivonaSU26CN60NSC189N2026-03-23
10887709188829BivonaXT26CS70NSC191N2026-03-23
10887709188713BivonaFT26CN40NSE186N2026-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194219BivonaICU MEDICAL, INC.JOH2026-05-26
10887709194141BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194158BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194165BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194189BivonaICU MEDICAL, INC.JOH2026-05-22
10887709194196BivonaICU MEDICAL, INC.JOH2026-05-22
10887709188720BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188737BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188744BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188751BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188836BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188843BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188850BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188874BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188881BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188904BivonaICU MEDICAL, INC.JOH2026-03-24
10887709188805BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188812BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188829BivonaICU MEDICAL, INC.JOH2026-03-23
10887709188713BivonaICU MEDICAL, INC.JOH2026-03-22
10887709188768BivonaICU MEDICAL, INC.JOH2026-03-22
10887709187921BivonaICU MEDICAL, INC.JOH2026-03-19
10887709187938BivonaICU MEDICAL, INC.JOH2026-03-19
10887709187945BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188645BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188652BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188669BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188676BivonaICU MEDICAL, INC.JOH2026-03-19
10887709188683BivonaICU MEDICAL, INC.JOH2026-03-19
20884521841724ShileyCovidien LPJOH2026-03-17