FDA.reportPublic FDA data

Bivona

Primary DI
15021312013689
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
60HA25
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
15021312013689PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131201368915021312013689

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile 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 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 to meet the individual needs of the patient. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use 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
10887709199870BivonaFU26GN40NSC236N2026-07-30
10887709199887BivonaFU26GN30NSC235N2026-07-30
10887709199894BivonaFU26GN30NSF235N2026-07-30
10887709199689BivonaFU26GN60NGF229N2026-07-29
10887709199696BivonaFT26GN45NSF228N2026-07-29
10887709199702BivonaST26GN50NGF231N2026-07-29
10887709199719BivonaFT26GN40NGF230N2026-07-29
10887709199726BivonaFT26GN65NSC225N2026-07-29
10887709199733BivonaSU26GN45NSC223N2026-07-29
10887709199740BivonaSU26GN40NSC222N2026-07-29
10887709199757BivonaFT26GN60NSF232N2026-07-29
10887709199658BivonaFT26GN25NSA221N2026-07-28
10887709199665BivonaST26GN55NSB224N2026-07-28
10887709198804BivonaFT26GN45NSF145N2026-07-27
10887709199252BivonaFU26GN50NSF160N2026-07-27
10887709199269BivonaFT26GN55NGF161N2026-07-27
10887709199276BivonaFP26GN40NSF163N2026-07-27
10887709199283BivonaFU26GN45NSA164N2026-07-27
10887709199290BivonaFT26GN40NGE162N2026-07-27
10887709199306BivonaFT26FN80NSC026S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709199870BivonaICU MEDICAL, INC.JOH2026-07-30
10887709199887BivonaICU MEDICAL, INC.JOH2026-07-30
10887709199894BivonaICU MEDICAL, INC.JOH2026-07-30
10887709199689BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199696BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199702BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199719BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199726BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199733BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199740BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199757BivonaICU MEDICAL, INC.JOH2026-07-29
10887709199658BivonaICU MEDICAL, INC.JOH2026-07-28
10887709199665BivonaICU MEDICAL, INC.JOH2026-07-28
10887709198804BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199252BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199269BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199276BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199283BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199290BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199306BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199313BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199320BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199337BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199344BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199351BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199450BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199467BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199474BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199481BivonaICU MEDICAL, INC.JOH2026-07-27
10887709199498BivonaICU MEDICAL, INC.JOH2026-07-27