Bivona

Primary DI
15019517106909
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU17EN50NSC910N
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
15019517106909PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951710690915019517106909

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
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16
10887709198446BivonaHT26GS60NSC097N2026-07-16
10887709198453BivonaHU26GS70NSB104N2026-07-16
10887709198460BivonaSU26GN50NGF113N2026-07-16
10887709198477BivonaFT26GN35NGE112N2026-07-16
10887709198484BivonaAT26GS70NSC096N2026-07-16
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709198415BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198422BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198439BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198446BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198453BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198460BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198477BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198484BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198163BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198170BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198187BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198194BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198200BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198217BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198224BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198231BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198248BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198255BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198262BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198279BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198286BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198293BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198309BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198316BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198323BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198330BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198033BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198040BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198057BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198071BivonaICU MEDICAL, INC.JOH2026-07-13