Bivona

Primary DI
10887709208305
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT26KN50NSC004N
Device description
FT26KN50NSC004N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-11-03
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
10887709208305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920830510887709208305

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
10887709208497BivonaFT26KN35NGE032N2026-11-05
10887709208503BivonaFT26KN35NSF033N2026-11-05
10887709208510BivonaST26KN80NSB035N2026-11-05
10887709208527BivonaFT26KN40NGF031N2026-11-05
10887709208572BivonaFT26KN50NGF039N2026-11-05
10887709208589BivonaST26KN80NSC040N2026-11-05
10887709208596BivonaXT26HS70NSC038N2026-11-05
10887709208602BivonaFT26KN55NGC034N2026-11-05
10887709208206BivonaHU26JS55NSB221N2026-11-04
10887709208213BivonaFT26JN40NSF243N2026-11-04
10887709208282BivonaFU26KN30NGA012N2026-11-03
10887709208299BivonaFT26KN50NGF011N2026-11-03
10887709208312BivonaFT26KN40NSF007N2026-11-03
10887709208329BivonaFT26KN40NGE003S2026-11-03
10887709208336BivonaFT26KN30NGE013N2026-11-03
10887709208343BivonaXT26JS50NGC230N2026-11-03
10887709208350BivonaFU26KN35NSF018N2026-11-03
10887709208367BivonaFU26KN30NSF019N2026-11-03
10887709208374BivonaFT26KN45NGF017N2026-11-03
10887709208381BivonaFT26KN40NGA014N2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709208497BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208503BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208510BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208527BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208572BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208589BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208596BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208602BivonaICU MEDICAL, INC.JOH2026-11-05
10887709208206BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208213BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208411BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208428BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208435BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208442BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208459BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208466BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208473BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208480BivonaICU MEDICAL, INC.JOH2026-11-04
10887709208282BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208299BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208312BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208329BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208336BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208343BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208350BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208367BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208374BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208381BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208398BivonaICU MEDICAL, INC.JOH2026-11-03
10887709208404BivonaICU MEDICAL, INC.JOH2026-11-03