Bivona

Primary DI
10887709207278
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU26JN55NGF168N
Device description
FU26JN55NGF168N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-10-23
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
10887709207278PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920727810887709207278

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
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23
10887709207360BivonaAT26JS30NGA177N2026-10-23
10887709207377BivonaAT26JS35NGA176N2026-10-23
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22
10887709207162BivonaFT26JN50NSF156N2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207230BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207247BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207254BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207261BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207339BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207346BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207353BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207360BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207377BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207100BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207117BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207124BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207131BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207148BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207155BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207162BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207179BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207193BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207209BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207216BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207223BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207032BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207049BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207056BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207063BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207070BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207087BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207094BivonaICU MEDICAL, INC.JOH2026-10-21
10887709206905BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206912BivonaICU MEDICAL, INC.JOH2026-10-20