Bivona

Primary DI
15021312000238
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
67SN025
Published
2015-09-01
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
K083641000
K914088000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K914088000BIVONA AIRE-CUF(R) PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies1991-10-23JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312000238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131200023815021312000238

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

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709146966LifeShield Infusion Safety Software Suite - DFM17002-032026-10-23
10887709146973LifeShield Infusion Safety Software Suite - DLM17003-032026-10-23
10887709146980LifeShield Infusion Safety Software Suite - CDR17005-032026-10-23
10887709155050LifeShield Infusion Safety Software Suite17000-032026-10-23
10887709207230BivonaFU26JN50NSF167N2026-10-23
10887709207247BivonaFU26JN40NSF171N2026-10-23
10887709207254BivonaFT26JN35NGF170N2026-10-23
10887709207261BivonaFT26JN40NSA166N2026-10-23
10887709207278BivonaFU26JN55NGF168N2026-10-23
10887709207339BivonaFT26JN30NGE178N2026-10-23
10887709207346BivonaFT26JN35NGF174N2026-10-23
10887709207353BivonaFT26JN35NGF175N2026-10-23
10887709207360BivonaAT26JS30NGA177N2026-10-23
10887709207377BivonaAT26JS35NGA176N2026-10-23
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207230BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207247BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207254BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207261BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207278BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207339BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207346BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207353BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207360BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207377BivonaICU MEDICAL, INC.JOH2026-10-23
10887709207100BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207117BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207124BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207131BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207148BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207155BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207162BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207179BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207193BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207209BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207216BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207223BivonaICU MEDICAL, INC.JOH2026-10-22
10887709207032BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207049BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207056BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207063BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207070BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207087BivonaICU MEDICAL, INC.JOH2026-10-21
10887709207094BivonaICU MEDICAL, INC.JOH2026-10-21
10887709206905BivonaICU MEDICAL, INC.JOH2026-10-20