Bivona

Primary DI
10887709194691
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
ST26EN55NTB208N
Device description
ST26EN55NTB208N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-06-02
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
10887709194691PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919469110887709194691

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
00887709170995ICU Medical, Inc.BAGH012026-06-02
10887709194660BivonaFP26FN45NGF003N2026-06-02
10887709194677BivonaST26EN60NTB206N2026-06-02
10887709194684BivonaST26EN60NTB207N2026-06-02
10887709194707BivonaST26EN55NTB209N2026-06-02
10887709194714BivonaFP26FN40NSA005N2026-06-02
10887709194721BivonaFU26FN35NSA006N2026-06-02
10887709194738BivonaFP26FN35NSA007N2026-06-02
10887709194745BivonaFT26FN35NGE008N2026-06-02
10887709194752BivonaHT26FS85NSC009N2026-06-02
10887709194769BivonaFT26FN40NGF012N2026-06-02
10887709194776BivonaFT26FN35NSE011N2026-06-02
10887709194783BivonaXT26FS50NSA010N2026-06-02
10887709193830BivonaZU26EN70NSC132N2026-06-01
10887709193847BivonaZU26EN75NSC131N2026-06-01
10887709194257BivonaSP26EN40NGE157S2026-06-01
10887709194264BivonaFF26EN55NSF148S2026-06-01
10887709194271BivonaSU26EN45NGG150N2026-06-01
10887709194288BivonaFU26EN35NSF173N2026-06-01
10887709194295BivonaFU26EN70NSC178N2026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194660BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194677BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194684BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194707BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194714BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194721BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194738BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194745BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194752BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194769BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194776BivonaICU MEDICAL, INC.JOH2026-06-02
10887709194783BivonaICU MEDICAL, INC.JOH2026-06-02
10887709193830BivonaICU MEDICAL, INC.JOH2026-06-01
10887709193847BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194257BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194264BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194271BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194288BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194295BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194301BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194318BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194332BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194349BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194363BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194370BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194387BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194394BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194400BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194417BivonaICU MEDICAL, INC.JOH2026-06-01
10887709194424BivonaICU MEDICAL, INC.JOH2026-06-01