Bivona

Primary DI
10887709205427
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU26JN40NGE003N
Device description
FU26JN40NGE003N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-10-01
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
10887709205427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920542710887709205427

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
10887709205281BivonaZT26IN40NGF212N2026-10-01
10887709205298BivonaZT26IN45NGF211N2026-10-01
10887709205304BivonaZT26IN45NGF210N2026-10-01
10887709205311BivonaSZ26IN60NGZ222N2026-10-01
10887709205328BivonaFT26IN35NGE217N2026-10-01
10887709205335BivonaHT26IS70NSC219N2026-10-01
10887709205342BivonaHT26IS80NSC218N2026-10-01
10887709205359BivonaSU26IN60NSC220N2026-10-01
10887709205366BivonaFT26IN40NGE221N2026-10-01
10887709205373BivonaFT26IN30NGF223N2026-10-01
10887709205380BivonaFU26JN50NGF001N2026-10-01
10887709205397BivonaHT26JS85NSC002N2026-10-01
10887709205410BivonaXA26JS60NGF004N2026-10-01
10887709205014BivonaFT26IN70NSZ174N2026-09-30
10887709205021BivonaZU26IS45NGF176N2026-09-30
10887709205038BivonaZU26IS40NGF175N2026-09-30
10887709205045BivonaZT26IN35NSB180N2026-09-30
10887709205052BivonaFU26IN40NGZ015N2026-09-30
10887709205069BivonaZT26IN50NGC149N2026-09-30
10887709205076BivonaZT26IN60NGC150N2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709205281BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205298BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205304BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205311BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205328BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205335BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205342BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205359BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205366BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205373BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205380BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205397BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205410BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205014BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205021BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205038BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205045BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205052BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205069BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205076BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205083BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205199BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205205BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205212BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205229BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205236BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205243BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205250BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205267BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205106BivonaICU MEDICAL, INC.JOH2026-09-29