Bivona

Primary DI
10887709132143
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
XT24IS50NGA112S
Device description
XT24IS50NGA112S Bivona DI Template: Non-Adjustable-Wired-Sterile
Published
2024-10-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
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
10887709132143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770913214310887709132143

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206776BivonaFT26JN55NGC127N2026-10-19
10887709206783BivonaXT26JS60NGC132N2026-10-19
10887709206813BivonaXT26JS40NGF130N2026-10-19
10887709206844BivonaFT26JN30NGF129N2026-10-19
10887709206851BivonaFT26JN60NSC131N2026-10-19
10887709206868BivonaFU26JN45NGA115N2026-10-19
10887709206875BivonaFT26JN35NGF133N2026-10-19
10887709206882BivonaSA26JN70NSC097N2026-10-19
10887709206899BivonaFU26HN40NGF206S2026-10-19
10887709206646BivonaSA26JN95NSC113N2026-10-16
10887709206653BivonaHA26JS85NSC114N2026-10-16
10887709206660BivonaHU26JS50NSC117N2026-10-16
10887709206677BivonaFT26JN35NSF119N2026-10-16
10887709206684BivonaFT26JN70NSC120N2026-10-16
10887709206691BivonaFU26JN50NGF118N2026-10-16
10887709206707BivonaAU26IS60NGC206S2026-10-16
10887709206714BivonaAT26JS50NGA116N2026-10-16
10887709206721BivonaFT26JN30NGF122N2026-10-16
10887709206738BivonaFT26JN35NGE124N2026-10-16
10887709206745BivonaXT26JS50NGC121N2026-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206776BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206783BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206813BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206844BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206851BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206868BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206875BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206882BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206899BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206646BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206653BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206660BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206677BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206684BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206691BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206707BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206714BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206721BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206738BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206745BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206752BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206769BivonaICU MEDICAL, INC.JOH2026-10-16
10887709206585BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206592BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206608BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206615BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206295BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206486BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206493BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206509BivonaICU MEDICAL, INC.JOH2026-10-14