Bivona

Primary DI
15019517251968
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT20LN35NGF060S
Published
2021-01-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
15019517251968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951725196815019517251968

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709197265BivonaZU26FN35NGE229N2026-07-09
10887709197289BivonaFT26FN70NSZ232N2026-07-09
10887709197838BivonaFT26GN55NGF037N2026-07-09
10887709197845BivonaST26GN55NGF038N2026-07-09
10887709197852BivonaFT26GN35NSF039N2026-07-09
10887709197869BivonaFT26GN35NSF043N2026-07-09
10887709197876BivonaFT26GN40NSF042N2026-07-09
10887709197883BivonaFU26GN35NGE044N2026-07-09
10887709197890BivonaFU26GN30NGE045N2026-07-09
10887709197906BivonaFP26GN25NGE046N2026-07-09
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709197722BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197739BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197746BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197753BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197760BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197777BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197784BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197791BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197807BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197586BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197593BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197609BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197616BivonaICU MEDICAL, INC.JOH2026-07-07