Bivona

Primary DI
10887709208121
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
HU26JS60NSB236N
Device description
HU26JS60NSB236N Bivona DI: Non-Adjustable-Wired_Non-Sterile
Published
2026-10-30
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
10887709208121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088770920812110887709208121

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
10887709208145BivonaFF26JN50NGF242N2026-11-02
10887709208152BivonaFT26JN60NGA245N2026-11-02
10887709208169BivonaAT26JS75NSC244N2026-11-02
10887709208176BivonaFT26JN40NSE240N2026-11-02
10887709208183BivonaFT26JN35NSE241N2026-11-02
10887709208190BivonaFT26JN55NGA246N2026-11-02
10887709208220BivonaFT26KN40NGE002N2026-11-02
10887709208237BivonaFT26KN35NGE001N2026-11-02
10887709208244BivonaFU26KN50NGF008N2026-11-02
10887709208251BivonaSA26KN95SSC006N2026-11-02
10887709208268BivonaSU26KN60NSC005N2026-11-02
10887709208275BivonaXA26KS60NSC009N2026-11-02
10887709207902BivonaFT26JN35NGE209S2026-10-30
10887709207933BivonaFU26JN45NSF227N2026-10-30
10887709207940BivonaAT26JS60NSC229N2026-10-30
10887709207957BivonaST26JN45NGF228N2026-10-30
10887709207964BivonaXT26JN50NGC230N2026-10-30
10887709207971BivonaFT26JN50NGC231N2026-10-30
10887709207988BivonaFT26JN50NGC232N2026-10-30
10887709208015BivonaXT26JS55NGF220N2026-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709208145BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208152BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208169BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208176BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208183BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208190BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208220BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208237BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208244BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208251BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208268BivonaICU MEDICAL, INC.JOH2026-11-02
10887709208275BivonaICU MEDICAL, INC.JOH2026-11-02
10887709207902BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207933BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207940BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207957BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207964BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207971BivonaICU MEDICAL, INC.JOH2026-10-30
10887709207988BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208015BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208022BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208039BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208046BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208053BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208060BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208077BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208084BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208091BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208107BivonaICU MEDICAL, INC.JOH2026-10-30
10887709208114BivonaICU MEDICAL, INC.JOH2026-10-30