Bivona

Primary DI
10887709205724
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU26JN40NSA006S
Device description
SU26JN40NSA006S Bivona DI: Non-Adjustable-Non-Wired-Sterile
Published
2026-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
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
10887709205724PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920572410887709205724

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.

Regulatory Flags#

DUNS number
118380146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
10887709205311BivonaICU MEDICAL, INC.JOH2026-10-01