Bivona

Primary DI
15019517246537
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU20JN40NGF860N
Published
2020-10-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
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
K923878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K923878000BIVONA CUSTOMIZED TRACHEOSTOMY TUBESBivona Medical Technologies1992-12-29JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15019517246537PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951724653715019517246537

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, 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 not custom-made for a specific patient and is not reinforced with a wire. 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. 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206585BivonaSA26JN95FSC110N2026-10-15
10887709206592BivonaFT26JN50NSA112N2026-10-15
10887709206608BivonaHT26JS80NSC111N2026-10-15
10887709206615BivonaFT26JN70NSC086N2026-10-15
10887709206295BivonaFT26JN40NGE075N2026-10-14
10887709206486BivonaFU26JN35NGE102N2026-10-14
10887709206493BivonaFU26JN30NGE103N2026-10-14
10887709206509BivonaFT26JN35NGF104N2026-10-14
10887709206516BivonaFU26JN55NGF105N2026-10-14
10887709206530BivonaXA26JS70NSC106N2026-10-14
10887709206561BivonaHU26JS60NSC107N2026-10-14
10887709206301BivonaFT26JN35NGC087N2026-10-13
10887709206318BivonaXT26JS40NSE095N2026-10-13
10887709206325BivonaFP26JN40NSA096N2026-10-13
10887709206349BivonaFT26JN40NGF099N2026-10-13
10887709206356BivonaFT26JN35NGF100N2026-10-13
10887709206363BivonaFT26JN50NGF089S2026-10-13
10887709206370BivonaST26JN60NSC088N2026-10-13
10887709206387BivonaSU26JN55NGF091N2026-10-13
10887709206394BivonaSU26JN55NGF090N2026-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206585BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206592BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206608BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206615BivonaICU MEDICAL, INC.JOH2026-10-15
10887709206295BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206486BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206493BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206509BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206516BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206530BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206561BivonaICU MEDICAL, INC.JOH2026-10-14
10887709206301BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206318BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206325BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206349BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206356BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206363BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206370BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206387BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206394BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206400BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206417BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206424BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206431BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206448BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206455BivonaICU MEDICAL, INC.JOH2026-10-13
10887709206172BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206189BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206196BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206202BivonaICU MEDICAL, INC.JOH2026-10-12