FDA.reportPublic FDA data

Bivona

Primary DI
10887709194462
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU26EN50NGF192N
Device description
SU26EN50NGF192N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Published
2026-05-28
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
10887709194462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770919446210887709194462

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
00887709098602ICU Medical, Inc.DS19022026-05-28
10887709194431BivonaFU26EN35NGE188N2026-05-28
10887709194448BivonaFU26EN35NGE189N2026-05-28
10887709194455BivonaXT26ES70NSC190N2026-05-28
10887709194486BivonaFT26EN35NGF193N2026-05-28
10887709194509BivonaFT26EN40NGF194N2026-05-28
10887709194226BivonaFT26EN35NSF182N2026-05-27
10887709194233BivonaFU26EN40NGA184N2026-05-27
10887709194240BivonaFT26EN60NSA185N2026-05-27
10887709194356BivonaFT26EN40NSF186N2026-05-27
00887709008045ICU MedicalB33382017-04-17
10887709194219BivonaFU26EN60NGC168N2026-05-26
10887709194141BivonaFT26EN40NGE171N2026-05-22
10887709194158BivonaSU26EN45NGG172N2026-05-22
10887709194165BivonaFU26EN35NGF174N2026-05-22
10887709194172BivonaFT26EN40NGF176N2026-05-22
10887709194189BivonaSU26EN50NGF175N2026-05-22
10887709194196BivonaFT26EN70NSC177N2026-05-22
10887709194073BivonaHT26ES60NSC163N2026-05-21
10887709194080BivonaFT26EN35NGF164N2026-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709194431BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194448BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194455BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194486BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194509BivonaICU MEDICAL, INC.JOH2026-05-28
10887709194226BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194233BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194240BivonaICU MEDICAL, INC.JOH2026-05-27
10887709194356BivonaICU MEDICAL, INC.JOH2026-05-27
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