Bivona

Primary DI
15019517185249
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU19CN40NGA943N
Published
2019-03-20
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
15019517185249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951718524915019517185249

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
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709196923BivonaICU MEDICAL, INC.JOH2026-07-17
10887709196954BivonaICU MEDICAL, INC.JOH2026-07-17
10887709197258BivonaICU MEDICAL, INC.JOH2026-07-17
10887709197388BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198149BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198637BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198644BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198651BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198668BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198675BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198682BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198699BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198705BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198712BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198729BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198736BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198743BivonaICU MEDICAL, INC.JOH2026-07-17
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