Bivona

Primary DI
15019517384635
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FU24EN45NGA040N
Published
2024-07-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
15019517384635PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951738463515019517384635

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
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16
10887709198446BivonaHT26GS60NSC097N2026-07-16
10887709198453BivonaHU26GS70NSB104N2026-07-16
10887709198460BivonaSU26GN50NGF113N2026-07-16
10887709198477BivonaFT26GN35NGE112N2026-07-16
10887709198484BivonaAT26GS70NSC096N2026-07-16
10887709198163BivonaFU26GN40NGE068N2026-07-14
10887709198170BivonaFU26GN50NGC069S2026-07-14
10887709198187BivonaFT26GN60NSF067N2026-07-14
10887709198194BivonaSU26GN40NGF073N2026-07-14
10887709198200BivonaFU26GN40NGA064N2026-07-14
10887709198217BivonaFT26GN40NGF074N2026-07-14
10887709198224BivonaFT26GN45SSF075N2026-07-14
10887709198231BivonaFT26GN30NSE076N2026-07-14
10887709198248BivonaFT26GN40NSE077N2026-07-14
10887709198255BivonaFT26GN60NGF078N2026-07-14
10887709198262BivonaFP26GN35ASF079N2026-07-14
10887709198279BivonaFT26GN35NGE080N2026-07-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709198415BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198422BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198439BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198446BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198453BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198460BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198477BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198484BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198163BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198170BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198187BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198194BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198200BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198217BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198224BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198231BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198248BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198255BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198262BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198279BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198286BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198293BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198309BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198316BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198323BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198330BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198033BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198040BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198057BivonaICU MEDICAL, INC.JOH2026-07-13
10887709198071BivonaICU MEDICAL, INC.JOH2026-07-13