FDA.reportPublic FDA data

Bivona

Primary DI
10887709194073
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
HT26ES60NSC163N
Device description
HT26ES60NSC163N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
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
10887709194073PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919407310887709194073

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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194080BivonaFT26EN35NGF164N2026-05-21
10887709194097BivonaFU26EN40NSE165N2026-05-21
10887709194103BivonaFT26EN60NGA166N2026-05-21
10887709194110BivonaFU26EN30NGE167N2026-05-21
10887709194127BivonaFU26EN30NGE170N2026-05-21
10887709194134BivonaFU26EN35NGE169N2026-05-21
00887709102460ICU Medical15687-2815687-282022-09-13
10887709192154BivonaZZ26DN35NGF198N2026-05-20
10887709193359BivonaZT26EN65NSZ072N2026-05-20
10887709193694BivonaZU26EN35NGE118N2026-05-20
10887709193779BivonaFU26DN35NGE237N2026-05-20
10887709193854BivonaFT26EN70NSC087N2026-05-20
10887709193861BivonaFT26EN75NSC086N2026-05-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884521177192ShileyCovidien LPJOH2021-10-05
10884521177208ShileyCovidien LPJOH2021-10-05
10884521177215ShileyCovidien LPJOH2021-10-05
10884521177222ShileyCovidien LPJOH2021-10-05
10884521177239ShileyCovidien LPJOH2021-10-05
10884521177178ShileyCovidien LPJOH2021-09-25
10884521177161ShileyCovidien LPJOH2021-09-11
10884521177154ShileyCovidien LPJOH2021-08-27
10884521177185ShileyCovidien LPJOH2021-08-24
10884521103535ShileyCovidien LPJOH2021-01-18
10884521103542ShileyCovidien LPJOH2021-01-18
10884521103559ShileyCovidien LPJOH2021-01-18
10884521103566ShileyCovidien LPJOH2021-01-18
10884521103573ShileyCovidien LPJOH2019-05-16
10884521103580ShileyCovidien LPJOH2019-05-16
10884521103597ShileyCovidien LPJOH2019-05-16
10884521103603ShileyCovidien LPJOH2019-05-16
10884521103450ShileyCovidien LPJOH2019-05-12
10884521103467ShileyCovidien LPJOH2019-05-12
10884521103474ShileyCovidien LPJOH2019-05-12
10884521103481ShileyCovidien LPJOH2019-05-12
10884521103498ShileyCovidien LPJOH2019-05-12
10884521103504ShileyCovidien LPJOH2019-05-12
10884521103511ShileyCovidien LPJOH2019-05-12
10884521103528ShileyCovidien LPJOH2019-05-12
10884521511910ShileyCovidien LPJOH2017-07-27
10884521511927ShileyCovidien LPJOH2017-07-27
10884521511934ShileyCovidien LPJOH2017-07-27
10884521511941ShileyCovidien LPJOH2017-07-27
10884521511958ShileyCovidien LPJOH2017-07-27