Bivona

Primary DI
10887709202471
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT26HN35NGE214N
Device description
FT26HN35NGE214N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-08-27
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
10887709202471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920247110887709202471

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
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26
10887709202327BivonaFT26HN60NSA192N2026-08-26
10887709202334BivonaFT26HN35NGF201N2026-08-26
10887709202341BivonaFT26HN35NGE195N2026-08-26
10887709202358BivonaST26HN55NSB202N2026-08-26
10887709202365BivonaST26HN50NSB203N2026-08-26
10887709202372BivonaFT26HN50NSF193N2026-08-26
10887709202389BivonaFT26HN35NGE196N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709201641BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202174BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202426BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202433BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202440BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202464BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202259BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202266BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202273BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202280BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202297BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202303BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202310BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202327BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202334BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202341BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202358BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202365BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202372BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202389BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202396BivonaICU MEDICAL, INC.JOH2026-08-26
10887709200071BivonaICU MEDICAL, INC.JOH2026-08-25
10887709201658BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202181BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202198BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202204BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202211BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202228BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202242BivonaICU MEDICAL, INC.JOH2026-08-25
10887709201009BivonaICU MEDICAL, INC.JOH2026-08-21