Bivona

Primary DI
15019517066968
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XT16HS40NGA015N
Published
2016-08-03
Public version status
Update
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
15019517066968PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951706696815019517066968

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
10887709197135BivonaXT26FS60NGC231N2026-07-08
10887709197142BivonaFT26FN35NGC234N2026-07-08
10887709197203BivonaFT26FN55NGC237N2026-07-08
10887709197210BivonaFT26FN35NSF236N2026-07-08
10887709197227BivonaFT26FN40NGE238N2026-07-08
10887709197234BivonaFT26FN40NGE239N2026-07-08
10887709197241BivonaFT26FN60NGC240N2026-07-08
10887709197722BivonaHT26GS70NSC029N2026-07-08
10887709197739BivonaFT26GN35NSE030N2026-07-08
10887709197746BivonaFT26GN30NSF031N2026-07-08
10887709197753BivonaFT26GN35NSF032N2026-07-08
10887709197760BivonaFT26GN30NSE034N2026-07-08
10887709197777BivonaSU16BN60NSC058N2026-07-08
10887709197784BivonaFT26GN30NGE036N2026-07-08
10887709197791BivonaFT26GN40NSE035N2026-07-08
10887709197807BivonaST16KN70TSC034S2026-07-08
10887709197586BivonaFT26GN40NSF014N2026-07-07
10887709197593BivonaFT26GN30NGE015N2026-07-07
10887709197609BivonaFT26GN40NGE016N2026-07-07
10887709197616BivonaFU26GN35NSF017N2026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709197135BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197142BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197203BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197210BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197227BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197234BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197241BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197722BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197739BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197746BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197753BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197760BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197777BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197784BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197791BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197807BivonaICU MEDICAL, INC.JOH2026-07-08
10887709197586BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197593BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197609BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197616BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197623BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197630BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197647BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197654BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197661BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197678BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197685BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197692BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197708BivonaICU MEDICAL, INC.JOH2026-07-07
10887709197715BivonaICU MEDICAL, INC.JOH2026-07-07