Bivona

Primary DI
15019517324396
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU22KN45NGG153N
Published
2024-04-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
15019517324396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951732439615019517324396

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, 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 not custom-made for a specific patient and is not reinforced with a wire. 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. 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
10887709205274BivonaZT26IN40NGF213N2026-10-06
10887709205519BivonaSZ26JN90NSC007N2026-10-06
10887709205526BivonaZT26JN80NTZ008N2026-10-06
10887709205533BivonaZT26JN65NSZ009N2026-10-06
10887709205793BivonaFU26JN45NGF018N2026-10-06
10887709205809BivonaFT26JN45NSF038N2026-10-06
10887709205816BivonaAU26JS80NSC037N2026-10-06
10887709205823BivonaXU26JS55NGF039N2026-10-06
10887709205830BivonaFU26JN35NGF041N2026-10-06
10887709205595BivonaFT26JN45NGF019N2026-10-05
10887709205601BivonaFU26KN45NGF018N2026-10-05
10887709205618BivonaFT26JN30NGF022N2026-10-05
10887709205625BivonaFT26JN40NSF023N2026-10-05
10887709205632BivonaFU26JN40NSC025N2026-10-05
10887709205649BivonaFU26JN40NSC024N2026-10-05
10887709205656BivonaXU26JS35NGA032N2026-10-05
10887709205663BivonaFT26JN30NGE031N2026-10-05
10887709205670BivonaFT26JN35NGE030N2026-10-05
10887709205700BivonaHU26JS70NSC035N2026-10-05
10887709205717BivonaFT26JN40NGE010N2026-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709205823BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205830BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205595BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205601BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205618BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205625BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205632BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205649BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205656BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205663BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205670BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205700BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205717BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205724BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205731BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205748BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205755BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205762BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205779BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205786BivonaICU MEDICAL, INC.JOH2026-10-05
10887709205281BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205298BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205304BivonaICU MEDICAL, INC.JOH2026-10-01