Bivona

Primary DI
15021312014754
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
60PFP55
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
K944178000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K944178000BIVONA FLEXTEND PEDIATRIC & NEONATAL TRACHEOSTROMY TUBESBivona Medical Technologies1994-10-27JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312014754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131201475415021312014754

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
10887709201016BivonaFU26HN30NSE091N2026-08-19
10887709201450BivonaFT26HN40NSF114N2026-08-19
10887709201504BivonaFT26HN30NSE122N2026-08-19
10887709201528BivonaFU26HN45NSA120N2026-08-19
10887709201535BivonaFU26HN40NSF117N2026-08-19
10887709201542BivonaFT26HN35NGF123N2026-08-19
10887709201559BivonaFT26HN50NSA119N2026-08-19
10887709201566BivonaFT26HN40NGF124N2026-08-19
10887709201573BivonaHT26HS80NSB126N2026-08-19
10887709201603BivonaFP26HN25NGE127N2026-08-19
10887709201610BivonaSU26HN35TGE116N2026-08-19
10887709201351BivonaAA26HS60NGC079N2026-08-18
10887709201368BivonaFT26HN60NGF108N2026-08-18
10887709201375BivonaFT26HN40NGF109N2026-08-18
10887709201399BivonaFU26HN60NGA111N2026-08-18
10887709201405BivonaFT26HN35NSA113N2026-08-18
10887709201412BivonaFT26HN40NGA090N2026-08-18
10887709201429BivonaFT26GN45NSF190N2026-08-18
10887709201436BivonaFU26HN30NGA098N2026-08-18
10887709201443BivonaFU26HN25NSA099N2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709201016BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201450BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201504BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201528BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201535BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201542BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201559BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201566BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201573BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201603BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201610BivonaICU MEDICAL, INC.JOH2026-08-19
10887709201351BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201368BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201375BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201399BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201405BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201412BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201429BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201436BivonaICU MEDICAL, INC.JOH2026-08-18
10887709201443BivonaICU MEDICAL, INC.JOH2026-08-18
10887709200873BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200880BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200897BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200903BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200910BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200927BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200941BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200958BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200965BivonaICU MEDICAL, INC.JOH2026-08-17
10887709200972BivonaICU MEDICAL, INC.JOH2026-08-17