Bivona

Primary DI
10887709206394
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
SU26JN55NGF090N
Device description
SU26JN55NGF090N Bivona DI: Non-Adjustable-Non-Wired-Non-Sterile
Published
2026-10-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
false
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
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
10887709206394PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920639410887709206394

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709206301BivonaFT26JN35NGC087N2026-10-13
10887709206318BivonaXT26JS40NSE095N2026-10-13
10887709206325BivonaFP26JN40NSA096N2026-10-13
10887709206349BivonaFT26JN40NGF099N2026-10-13
10887709206356BivonaFT26JN35NGF100N2026-10-13
10887709206363BivonaFT26JN50NGF089S2026-10-13
10887709206370BivonaST26JN60NSC088N2026-10-13
10887709206387BivonaSU26JN55NGF091N2026-10-13
10887709206400BivonaFU26JN35NSA094N2026-10-13
10887709206417BivonaFU26JN35NSA093N2026-10-13
10887709206424BivonaFU26JN35NSA092N2026-10-13
10887709206431BivonaSA26JN75NSC097N2026-10-13
10887709206448BivonaFU26JN55NGF098N2026-10-13
10887709206455BivonaFU26JN60NSF101N2026-10-13
10887709206172BivonaFU26JN30NSF074N2026-10-12
10887709206189BivonaFU26JN35NSF073N2026-10-12
10887709206196BivonaFT26JN40NGF076N2026-10-12
10887709206202BivonaST26JN55NSC078N2026-10-12
10887709206219BivonaHA26JS60NSB077N2026-10-12
10887709206226BivonaFT26JN60NSC079N2026-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
10887709206219BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206226BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206233BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206240BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206257BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206264BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206271BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206288BivonaICU MEDICAL, INC.JOH2026-10-12
10887709206103BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206110BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206127BivonaICU MEDICAL, INC.JOH2026-10-09
10887709206134BivonaICU MEDICAL, INC.JOH2026-10-09