Bivona

Primary DI
10887709133430
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU24IN35NGA246N
Device description
FU24IN35NGA246N 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
10887709133430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770913343010887709133430

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197814BivonaSU26EN50NSF192S2026-07-10
10887709197821BivonaFT26GN35NSE028N2026-07-10
10887709197913BivonaFU26GN50NGF047N2026-07-10
10887709197920BivonaFU26GN50NGF049N2026-07-10
10887709197944BivonaFT26GN70NSD050N2026-07-10
10887709197951BivonaFU26GN45NGF051N2026-07-10
10887709197968BivonaXT26GS80NSC052N2026-07-10
10887709197975BivonaFT26GN30NGE053N2026-07-10
10887709197982BivonaFT26GN40NGE054N2026-07-10
10887709197999BivonaFA26GN80NSC055N2026-07-10
10887709198002BivonaHU26GS45NSC040N2026-07-10
10887709198019BivonaFT26GN40NSE041N2026-07-10
10887709198026BivonaFU26GN35NGF048N2026-07-10
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197814BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197821BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197913BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197920BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197944BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197951BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197968BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197975BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197982BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197999BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198002BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198019BivonaICU MEDICAL, INC.JOH2026-07-10
10887709198026BivonaICU MEDICAL, INC.JOH2026-07-10
10887709197265BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197289BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197838BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197845BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197852BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197869BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197876BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197883BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197890BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197906BivonaICU MEDICAL, INC.JOH2026-07-09
10887709197135BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197142BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197203BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197210BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197227BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197234BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197241BivonaICU MEDICAL, INC.JOH2026-07-08