FDA.reportPublic FDA data

Bivona

Primary DI
15021312015652
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
60AFHXL80
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
K081440000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081440000BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2008-09-12JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312015652PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131201565215021312015652

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
10887709207919BivonaFT26JN30NGF219N2026-10-29
10887709207926BivonaHT26JS70NSC222N2026-10-29
M335400011ICU Medical, INC.400012025-04-28
M335400031ICU Medical, INC.400022025-04-28
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709207919BivonaICU MEDICAL, INC.JOH2026-10-29
10887709207926BivonaICU MEDICAL, INC.JOH2026-10-29
10887709207735BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207742BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207759BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207766BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207773BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207780BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207797BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207803BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207810BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207827BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207834BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207841BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207858BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207865BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207872BivonaICU MEDICAL, INC.JOH2026-10-28
10887709207285BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207292BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207308BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207315BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207322BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207445BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207452BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207469BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207476BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207483BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207490BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207506BivonaICU MEDICAL, INC.JOH2026-10-27
10887709207513BivonaICU MEDICAL, INC.JOH2026-10-27