Bivona

Primary DI
10887709207544
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU26JN40NGF182N
Device description
SU26JN40NGF182N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Published
2026-10-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
10887709207544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920754410887709207544

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
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27
10887709207292BivonaSA26JN75NSC152N2026-10-27
10887709207308BivonaSU26JN40NSB163S2026-10-27
10887709207315BivonaFU26JN45NSF173N2026-10-27
10887709207322BivonaXT26JS80NSC172N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207735BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207742BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207759BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207766BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207773BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207780BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207797BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207803BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207810BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207827BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207834BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207841BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207858BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207865BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207872BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207285BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207292BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207308BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207315BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207322BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207445BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207452BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207469BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207476BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207483BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207490BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207506BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207513BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207520BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207537BivonaICU MEDICAL, INC.JOH2026-10-27