FDA.reportPublic FDA data

Bivona

Primary DI
10887709130903
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT24HN40NGF222N
Device description
FT24HN40NGF222N Bivona DI Template: Non-Adjustable-Wired_Non-Sterile
Published
2024-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
10887709130903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770913090310887709130903

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
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
10887709208305BivonaFT26KN50NSC004N2026-11-03
10887709208312BivonaFT26KN40NSF007N2026-11-03
10887709208329BivonaFT26KN40NGE003S2026-11-03
10887709208336BivonaFT26KN30NGE013N2026-11-03
10887709208343BivonaXT26JS50NGC230N2026-11-03
10887709208350BivonaFU26KN35NSF018N2026-11-03
10887709208367BivonaFU26KN30NSF019N2026-11-03
10887709208374BivonaFT26KN45NGF017N2026-11-03

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
10887709208305BivonaICU 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