Bivona

Primary DI
10887709206363
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT26JN50NGF089S
Device description
FT26JN50NGF089S Bivona DI: Non-Adjustable-Wired-Sterile
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
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
10887709206363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920636310887709206363

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.

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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206301BivonaFT26JN35NGC087N2026-10-13
10887709206318BivonaXT26JS40NSE095N2026-10-13
10887709206325BivonaFP26JN40NSA096N2026-10-13
10887709206349BivonaFT26JN40NGF099N2026-10-13
10887709206356BivonaFT26JN35NGF100N2026-10-13
10887709206370BivonaST26JN60NSC088N2026-10-13
10887709206387BivonaSU26JN55NGF091N2026-10-13
10887709206394BivonaSU26JN55NGF090N2026-10-13
10887709206400BivonaFU26JN35NSA094N2026-10-13
10887709206417BivonaFU26JN35NSA093N2026-10-13
10887709206424BivonaFU26JN35NSA092N2026-10-13
10887709206431BivonaSA26JN75NSC097N2026-10-13
10887709206448BivonaFU26JN55NGF098N2026-10-13
10887709206455BivonaFU26JN60NSF101N2026-10-13
10887709206172BivonaFU26JN30NSF074N2026-10-12
10887709206189BivonaFU26JN35NSF073N2026-10-12
10887709206196BivonaFT26JN40NGF076N2026-10-12
10887709206202BivonaST26JN55NSC078N2026-10-12
10887709206219BivonaHA26JS60NSB077N2026-10-12
10887709206226BivonaFT26JN60NSC079N2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206301BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206318BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206325BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206349BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206356BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206370BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206387BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206394BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206400BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206417BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206424BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206431BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206448BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206455BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206172BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206189BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206196BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206202BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206219BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206226BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206233BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206240BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206257BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206264BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206271BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206288BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206103BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206110BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206127BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206134BivonaICU MEDICAL, INC.JOH2026-10-09