Bivona

Primary DI
15019517282986
Brand
Bivona
Company
ICU MEDICAL, INC.
Model
FT21JN30NGE062N
Published
2021-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
15019517282986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1501951728298615019517282986

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
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
10887709196923BivonaST26FN85ZSZ174N2026-07-17
10887709196954BivonaFT26FN70NSZ162N2026-07-17
10887709197258BivonaZU26FN70NSC221N2026-07-17
10887709197388BivonaZZ26FN95NSC253N2026-07-17
10887709198149BivonaZU26GN45NGF066N2026-07-17
10887709198637BivonaFU26GN35NSF119N2026-07-17
10887709198644BivonaST26GN60NSC115N2026-07-17
10887709198651BivonaSU26GN60NSC123N2026-07-17
10887709198668BivonaFT26GN35NGE124N2026-07-17
10887709198675BivonaFT26GN30NGE125N2026-07-17
10887709198682BivonaHT26GS95NSC118N2026-07-17
10887709198699BivonaFU26GN45NGF128N2026-07-17
10887709198705BivonaFT26GN40NGE126N2026-07-17
10887709198712BivonaFT26GN35NGE127N2026-07-17
10887709198729BivonaFT26GN40NGF129N2026-07-17
10887709198736BivonaFT26GN60NGA130N2026-07-17
10887709198743BivonaFT26GN40NSE131N2026-07-17
10887709198415BivonaST26GN30NGF103N2026-07-16
10887709198422BivonaST26GN55NSC102N2026-07-16
10887709198439BivonaST26GN45NGF098N2026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709196923BivonaICU MEDICAL, INC.JOH2026-07-17
10887709196954BivonaICU MEDICAL, INC.JOH2026-07-17
10887709197258BivonaICU MEDICAL, INC.JOH2026-07-17
10887709197388BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198149BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198637BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198644BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198651BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198668BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198675BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198682BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198699BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198705BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198712BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198729BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198736BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198743BivonaICU MEDICAL, INC.JOH2026-07-17
10887709198415BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198422BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198439BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198446BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198453BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198460BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198477BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198484BivonaICU MEDICAL, INC.JOH2026-07-16
10887709198163BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198170BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198187BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198194BivonaICU MEDICAL, INC.JOH2026-07-14
10887709198200BivonaICU MEDICAL, INC.JOH2026-07-14