Bivona

Primary DI
15021312005776
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
60P050
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
BTOTube, tracheostomy (w/wo connector)
JOHTube tracheostomy and tube cuff

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2
JOHTube Tracheostomy And Tube CuffAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083641000
K912469000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083641000BIVONA TRACHEOSTOMY TUBESSmiths Medical Asd, Inc.2009-02-23JOH
K912469000BIVONA WIRE REINFORCED PEDIATRIC TRACHEOSTOMY TUBEBivona Medical Technologies1991-06-19BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15021312005776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1502131200577615021312005776

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
10887709201641BivonaZT26DN50NSZ214S2026-08-27
10887709202174BivonaST26HN80ZSZ137N2026-08-27
10887709202426BivonaFT26HN45NSF207N2026-08-27
10887709202433BivonaFU26HN40NGF213N2026-08-27
10887709202440BivonaFT26HN45NGA211N2026-08-27
10887709202464BivonaFT26HN30NGE215N2026-08-27
10887709202471BivonaFT26HN35NGE214N2026-08-27
10887709202259BivonaFU26HN35NGA187N2026-08-26
10887709202266BivonaFT26HN35NGE188N2026-08-26
10887709202273BivonaFU26HN40NGA186N2026-08-26
10887709202280BivonaFT26HN35NGF189N2026-08-26
10887709202297BivonaFU26HN40NGF190N2026-08-26
10887709202303BivonaFT26HN40NSE076N2026-08-26
10887709202310BivonaFU26HN25NGE191N2026-08-26
10887709202327BivonaFT26HN60NSA192N2026-08-26
10887709202334BivonaFT26HN35NGF201N2026-08-26
10887709202341BivonaFT26HN35NGE195N2026-08-26
10887709202358BivonaST26HN55NSB202N2026-08-26
10887709202365BivonaST26HN50NSB203N2026-08-26
10887709202372BivonaFT26HN50NSF193N2026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709201641BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202174BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202426BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202433BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202440BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202464BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202471BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202259BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202266BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202273BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202280BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202297BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202303BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202310BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202327BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202334BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202341BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202358BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202365BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202372BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202389BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202396BivonaICU MEDICAL, INC.JOH2026-08-26
10887709200071BivonaICU MEDICAL, INC.JOH2026-08-25
10887709201658BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202181BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202198BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202204BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202211BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202228BivonaICU MEDICAL, INC.JOH2026-08-25
10887709202242BivonaICU MEDICAL, INC.JOH2026-08-25