Bivona

Primary DI
15021312006971
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
85N040
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
K913859000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K913859000BIVONA FOME-CUF(R) & AIR CUF(R), MODIFICATIONBivona Medical Technologies1992-01-30JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312006971PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131200697115021312006971

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
10887709207100BivonaXU26JS40NGE159N2026-10-22
10887709207117BivonaFU26JN60NSC161N2026-10-22
10887709207124BivonaFU26JN50NGC162N2026-10-22
10887709207131BivonaHU26JS70NSC158N2026-10-22
10887709207148BivonaFT26JN40NGF157N2026-10-22
10887709207155BivonaFT26JN35NGE140N2026-10-22
10887709207162BivonaFT26JN50NSF156N2026-10-22
10887709207179BivonaFT26JN65NSC160N2026-10-22
10887709207193BivonaFT26JN60NSC164N2026-10-22
10887709207209BivonaFT26JN35NGF165N2026-10-22
10887709207216BivonaAT26JS35NSA151N2026-10-22
10887709207223BivonaAT26JS40NSA150N2026-10-22
10887709207032BivonaFT26JN30NGE149N2026-10-21
10887709207049BivonaFT26JN35NGE148N2026-10-21
10887709207056BivonaFT26JN40NGE145N2026-10-21
10887709207063BivonaXU26JS50NSC147N2026-10-21
10887709207070BivonaFT26IN40NSF242N2026-10-21
10887709207087BivonaFU26JN60NGA155N2026-10-21
10887709207094BivonaFU26JN40NGF146N2026-10-21
10887709206905BivonaFU26JN40NSC136N2026-10-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10887709206912BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206936BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206950BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206967BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206974BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206981BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206998BivonaICU MEDICAL, INC.JOH2026-10-20
10887709207001BivonaICU MEDICAL, INC.JOH2026-10-20
10887709206776BivonaICU MEDICAL, INC.JOH2026-10-19
10887709206783BivonaICU MEDICAL, INC.JOH2026-10-19