Bivona

Primary DI
10887709197562
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU26GN50NSF012N
Device description
FU26GN50NSF012N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-07-06
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
10887709197562PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919756210887709197562

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
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
10887709197579BivonaFT26GN35NGF013N2026-07-06
15019517382860ICU Medical, Inc.011-100/892/200CZ2026-07-06
10887709195131BivonaST26FN50NGF055N2026-06-08

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
10887709197579BivonaICU MEDICAL, INC.JOH2026-07-06
10887709195131BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195148BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195155BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195162BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195179BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195186BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195193BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195209BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195216BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195223BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195230BivonaICU MEDICAL, INC.JOH2026-06-08
10887709195247BivonaICU MEDICAL, INC.JOH2026-06-08