Bivona

Primary DI
10887709194998
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XU26FS35NGA037N
Device description
XU26FS35NGA037N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-06-05
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
10887709194998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919499810887709194998

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
10887709194967BivonaFT26FN40NSF031N2026-06-05
10887709194974BivonaFU26FN35NGF035N2026-06-05
10887709194981BivonaFU26FN40NGE036N2026-06-05
10887709195001BivonaXU26FS35NGA038N2026-06-05
10887709195018BivonaXU26FS35NGA039N2026-06-05
10887709195025BivonaXU26FS55NGC029N2026-06-05
10887709195032BivonaFT26FN45NSF030N2026-06-05
10887709195049BivonaFU26FN60NSA032N2026-06-05
10887709195056BivonaFT26FN25NGE033N2026-06-05
10887709195063BivonaFT26FN30NGE034N2026-06-05
10887709195070BivonaHT26FS70NSC042N2026-06-05
10887709195087BivonaSU26FN35NGF041N2026-06-05
10887709195094BivonaFT26FN30NGF045N2026-06-05
10887709195100BivonaFT26FN25NGF044N2026-06-05
10887709195117BivonaFA26FN70NSC047N2026-06-05
10887709195124BivonaFU26FN70NTC048N2026-06-05
10887709194899BivonaFU26FN35NGE024N2026-06-04
10887709194905BivonaFT26FN40NGE027N2026-06-04
10887709194912BivonaFU26FN40NGE028N2026-06-04
10887709194929BivonaXT26FS50NSF019N2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194967BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194974BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194981BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195001BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195018BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195025BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195032BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195049BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195056BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195063BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195070BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195087BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195094BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195100BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195117BivonaICU MEDICAL, INC.JOH2026-06-05
10887709195124BivonaICU MEDICAL, INC.JOH2026-06-05
10887709194899BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194905BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194912BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194929BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194936BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194943BivonaICU MEDICAL, INC.JOH2026-06-04
10887709194585BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194615BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194790BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194806BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194813BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194820BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194837BivonaICU MEDICAL, INC.JOH2026-06-03
10887709194844BivonaICU MEDICAL, INC.JOH2026-06-03