Bivona

Primary DI
10887709199047
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU26GN35NGE152N
Device description
FU26GN35NGE152N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10887709199047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919904710887709199047

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, reinforced, non-customized, reusableAn armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.

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
10887709199061BivonaFT26GN50NGF159N2026-07-22
10887709198095BivonaFT26GN40NGF059N2026-07-21
10887709198521BivonaST26GN65NSC093N2026-07-21
10887709198897BivonaHT26GS50NSC139N2026-07-21
10887709198903BivonaHU26GS50NSC140N2026-07-21
10887709198910BivonaFU26GN45NSF142N2026-07-21
10887709198927BivonaFT26GN60NSF137N2026-07-21
10887709198934BivonaFT26GN70NSC136N2026-07-21
10887709198965BivonaXT26GS60NGF149N2026-07-21
10887709198972BivonaFT26GN40NSF150N2026-07-21
10887709198996BivonaFU26GN40NSF151N2026-07-21
10887709199009BivonaFT26GN45NSF147N2026-07-21
10887709199016BivonaFU26GN50NSF146N2026-07-21
10887709199023BivonaFU26GN45NGF148N2026-07-21
10887709199030BivonaFU26GN30NGE153N2026-07-21
10887709199054BivonaXU26GS45NGF154N2026-07-21
10887709198491BivonaSU26EN50NGF192S2026-07-20
10887709198507BivonaSU26GN40NGF092N2026-07-20
10887709198514BivonaFT26GN60NSC091N2026-07-20
10887709198538BivonaFU20GN45NGF086N2026-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709198996BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199009BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199016BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199023BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199030BivonaICU MEDICAL, INC.JOH2026-07-21
10887709199054BivonaICU MEDICAL, INC.JOH2026-07-21
10887709198491BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198507BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198514BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198538BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198545BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198552BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198576BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198583BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198590BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198606BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198613BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198620BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198767BivonaICU MEDICAL, INC.JOH2026-07-20
10887709198774BivonaICU MEDICAL, INC.JOH2026-07-20