Bivona

Primary DI
10887709198873
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
ZU26GN75NSC099N
Device description
ZU26GN75NSC099N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Published
2026-07-23
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
10887709198873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919887310887709198873

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
10887709197272BivonaFT26FN70NSZ233N2026-07-23
10887709198392BivonaSU26GN80NZC083N2026-07-23
10887709198408BivonaZA26GN85NSC085N2026-07-23
10887709198750BivonaSZ26GN70ZSZ114N2026-07-23
10887709198941BivonaZU26GN60NGF143N2026-07-23
10887709198958BivonaZU26GN55NGF144N2026-07-23
10887709199085BivonaFU26GN35NGF169N2026-07-23
10887709199092BivonaFT26GN35NGA089N2026-07-23
10887709199108BivonaFT26GN35NGE166N2026-07-23
10887709199115BivonaST26GN40NGF165N2026-07-23
10887709199146BivonaFT26GN55NGC172N2026-07-23
10887709199153BivonaFU26GN55NGC170N2026-07-23
10887709199160BivonaFT26GN50NGC171N2026-07-23
10887709199177BivonaFU26GN40NGA178N2026-07-23
10887709199184BivonaFU26GN55NSF173N2026-07-23
10887709199207BivonaST26GN50NSC177N2026-07-23
10887709199214BivonaFT26GN30NGF174N2026-07-23
10887709199221BivonaST26GN55NSC176N2026-07-23
10887709199238BivonaFT26GN40NGE175N2026-07-23
10887709199245BivonaFU26GN35NSF181N2026-07-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197272BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198392BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198408BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198750BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198941BivonaICU MEDICAL, INC.JOH2026-07-23
10887709198958BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199085BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199092BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199108BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199115BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199146BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199153BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199160BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199177BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199184BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199207BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199214BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199221BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199238BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199245BivonaICU MEDICAL, INC.JOH2026-07-23
10887709199061BivonaICU MEDICAL, INC.JOH2026-07-22
10887709198095BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198521BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198897BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198903BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198910BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198927BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198934BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198965BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198972BivonaICU MEDICAL, INC.JOH2026-07-21