Bivona

Primary DI
10887709206035
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FP26JN35NGE061N
Device description
FP26JN35NGE061N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
10887709206035PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920603510887709206035

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, reinforced, non-customized, reusableAn armoured, hollow cylinder that is inserted into an artificial opening made in the trachea (windpipe) during a tracheotomy to provide a patent airway, typically for a patient with unusual neck mass, however it is not custom-made for a specific patient. It is constructed of plastic with wire reinforcement to provide additional resistance to kinking and may include an inner cannula. It is available in cuffed, uncuffed versions, and in a variety of sizes. It is typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-patient, reusable device after appropriate cleaning.

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
10887709206011BivonaXU26JS35NGF064N2026-10-08
10887709206028BivonaFT26JN45NGF062N2026-10-08
10887709206042BivonaFU26JN35NGA059N2026-10-08
10887709206059BivonaXU26JS35NGA058N2026-10-08
10887709206073BivonaFT26JN55NSF056N2026-10-08
10887709206080BivonaST26JN50NGG057N2026-10-08
10887709205687BivonaFT26JN35NGF033N2026-10-07
10887709205694BivonaFT26JN35NGE208N2026-10-07
10887709205847BivonaSU26JN65NSC047N2026-10-07
10887709205854BivonaSU26JN65NSC048N2026-10-07
10887709205861BivonaXT26JS80NSC050N2026-10-07
10887709205878BivonaXT26JS80NSC051N2026-10-07
10887709205885BivonaFU26JN35NGE052N2026-10-07
10887709205892BivonaFU26JN30NGE053N2026-10-07
10887709205908BivonaFU26JN55NGF046N2026-10-07
10887709205915BivonaFT26JN45NSC045N2026-10-07
10887709205922BivonaSU26JS65NSC049N2026-10-07
10887709205939BivonaFT26JN35NGE043N2026-10-07
10887709205946BivonaFT26JN40NGE044N2026-10-07
10887709205953BivonaFT26JN65NSD055N2026-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709206011BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206028BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206042BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206059BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206073BivonaICU MEDICAL, INC.JOH2026-10-08
10887709206080BivonaICU MEDICAL, INC.JOH2026-10-08
10887709205687BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205694BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205847BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205854BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205861BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205878BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205885BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205892BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205908BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205915BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205922BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205939BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205946BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205953BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205960BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205991BivonaICU MEDICAL, INC.JOH2026-10-07
10887709205274BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205519BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205526BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205533BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205793BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205809BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205816BivonaICU MEDICAL, INC.JOH2026-10-06
10887709205823BivonaICU MEDICAL, INC.JOH2026-10-06