Bivona

Primary DI
10351688836717
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU15BN35NSC329N
Published
2015-09-24
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
10351688836717PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168883671710351688836717

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, reusableA hollow cylinder designed to be inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway; it is not custom-made for a specific patient and is not reinforced with a wire. It is typically constructed of metal [stainless steel, silver (Ag) and/or silver plated brass] or plastic and may include an inner cannula. It is available in cuffed, uncuffed, and/or fenestrated versions, and in a variety of shapes and sizes. It is secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198873BivonaZU26GN75NSC099N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197272BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198392BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198408BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198750BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198873BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198941BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198958BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199085BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199092BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199108BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199115BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199146BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199153BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199160BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199177BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199184BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199207BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199214BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199221BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199238BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199245BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199061BivonaICU MEDICAL, INC.JOH2026-07-22
10887709198095BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198521BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198897BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198903BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198910BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198927BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198934BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198965BivonaICU MEDICAL, INC.JOH2026-07-21