Bivona

Primary DI
15019517162110
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XU18HS60NSC941N
Published
2018-08-17
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
15019517162110PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951716211015019517162110

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, 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 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 (however is not custom-made for a specific patient). 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
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
10887709205281BivonaZT26IN40NGF212N2026-10-01
10887709205298BivonaZT26IN45NGF211N2026-10-01
10887709205304BivonaZT26IN45NGF210N2026-10-01
10887709205311BivonaSZ26IN60NGZ222N2026-10-01
10887709205328BivonaFT26IN35NGE217N2026-10-01
10887709205335BivonaHT26IS70NSC219N2026-10-01
10887709205342BivonaHT26IS80NSC218N2026-10-01
10887709205359BivonaSU26IN60NSC220N2026-10-01
10887709205366BivonaFT26IN40NGE221N2026-10-01
10887709205373BivonaFT26IN30NGF223N2026-10-01
10887709205380BivonaFU26JN50NGF001N2026-10-01
10887709205397BivonaHT26JS85NSC002N2026-10-01
10887709205410BivonaXA26JS60NGF004N2026-10-01
10887709205427BivonaFU26JN40NGE003N2026-10-01
10887709205014BivonaFT26IN70NSZ174N2026-09-30
10887709205021BivonaZU26IS45NGF176N2026-09-30
10887709205038BivonaZU26IS40NGF175N2026-09-30
10887709205045BivonaZT26IN35NSB180N2026-09-30
10887709205052BivonaFU26IN40NGZ015N2026-09-30
10887709205069BivonaZT26IN50NGC149N2026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709205281BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205298BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205304BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205311BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205328BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205335BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205342BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205359BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205366BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205373BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205380BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205397BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205410BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205427BivonaICU MEDICAL, INC.JOH2026-10-01
10887709205014BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205021BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205038BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205045BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205052BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205069BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205076BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205083BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205199BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205205BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205212BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205229BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205236BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205243BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205250BivonaICU MEDICAL, INC.JOH2026-09-30
10887709205267BivonaICU MEDICAL, INC.JOH2026-09-30