Bivona

Primary DI
15019517227635
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT20EN60NGF993N
Published
2020-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
15019517227635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951722763515019517227635

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, 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 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 (however is not custom-made for a specific patient). 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
10887709206905BivonaFU26JN40NSC136N2026-10-20
10887709206912BivonaFT26JN35NSE138N2026-10-20
10887709206936BivonaFT26JN60NSF126N2026-10-20
10887709206950BivonaFU26JN30NSE134N2026-10-20
10887709206967BivonaFU26JN35NSE135N2026-10-20
10887709206974BivonaFU26JN30NSF137N2026-10-20
10887709206981BivonaFT26JN40NSE142N2026-10-20
10887709206998BivonaFT26JN35NSE143N2026-10-20
10887709207001BivonaSU26JN50NSB144N2026-10-20
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206905BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206912BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206936BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206950BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206967BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206974BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206981BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206998BivonaICU MEDICAL, INC.JOH2026-10-20
10887709207001BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206776BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206783BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206813BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206844BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206851BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206868BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206875BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206882BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206899BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206646BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206653BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206660BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206677BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206684BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206691BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206707BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206714BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206721BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206738BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206745BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206752BivonaICU MEDICAL, INC.JOH2026-10-16