Bivona

Primary DI
15019517134421
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XU17LS45NSC947N
Published
2017-12-12
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
15019517134421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951713442115019517134421

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
10887709206011BivonaXU26JS35NGF064N2026-10-08
10887709206028BivonaFT26JN45NGF062N2026-10-08
10887709206035BivonaFP26JN35NGE061N2026-10-08
10887709206042BivonaFU26JN35NGA059N2026-10-08
10887709206059BivonaXU26JS35NGA058N2026-10-08
10887709206073BivonaFT26JN55NSF056N2026-10-08
10887709206080BivonaST26JN50NGG057N2026-10-08
10887709205687BivonaFT26JN35NGF033N2026-10-07
10887709205694BivonaFT26JN35NGE208N2026-10-07
10887709205847BivonaSU26JN65NSC047N2026-10-07
10887709205854BivonaSU26JN65NSC048N2026-10-07
10887709205861BivonaXT26JS80NSC050N2026-10-07
10887709205878BivonaXT26JS80NSC051N2026-10-07
10887709205885BivonaFU26JN35NGE052N2026-10-07
10887709205892BivonaFU26JN30NGE053N2026-10-07
10887709205908BivonaFU26JN55NGF046N2026-10-07
10887709205915BivonaFT26JN45NSC045N2026-10-07
10887709205922BivonaSU26JS65NSC049N2026-10-07
10887709205939BivonaFT26JN35NGE043N2026-10-07
10887709205946BivonaFT26JN40NGE044N2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206011BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206028BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206035BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206042BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206059BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206073BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206080BivonaICU MEDICAL, INC.JOH2026-10-08
10887709205687BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205694BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205847BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205854BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205861BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205878BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205885BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205892BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205908BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205915BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205922BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205939BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205946BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205953BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205960BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205991BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205274BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205519BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205526BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205533BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205793BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205809BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205816BivonaICU MEDICAL, INC.JOH2026-10-06