Portex

Primary DI
15019315015854
Brand
Portex
Company
ICU MEDICAL, INC.
Model
100/527/060
Published
2015-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K962175000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K962175000PORTEX ADJUSTABLE FLANGE TRACHEOSTOMY TUBESmiths Industries Medical Systems, Inc.1997-01-17JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315015858PackageGS12In Commercial Distribution
55019315015852PackageGS110In Commercial Distribution
15019315015854PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931501585835019315015858
5501931501585255019315015852
1501931501585415019315015854

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy tube, non-reinforced, non-customized, single-useA 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 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 typically secured in position by a tracheostomy tube holder fastened around the patient's neck. This is a single-use device.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887709190207ICU Medical, Inc.PA03-XS2026-08-07
00887709190214ICU Medical, Inc.PA03LL-XS2026-08-07
10887709200668BivonaFT26HN35NGF055N2026-08-07
10887709200675BivonaFT26HN55NGC058N2026-08-07
10887709200682BivonaFT26HN60NGC056N2026-08-07
10887709200699BivonaFU26HN55NGC057N2026-08-07
10887709200705BivonaFT26HN35NGE053N2026-08-07
10887709200729BivonaFU26HN35NGE059N2026-08-07
10887709200736BivonaFU26HN35NGA060N2026-08-07
10887709200767BivonaFU26HN30NSF063N2026-08-07
10887709200781BivonaFU26HN45NGA065N2026-08-07
10887709198385BivonaXZ26GS70NSC058N2026-08-03
10887709198866BivonaFU26GN40NSZ134N2026-08-03
10887709198880BivonaXU26GS55NGZ141N2026-08-03
10887709199368BivonaZT26GN95ZSZ155N2026-08-03
10887709199580BivonaFT26GN45NSE190N2026-08-03
10887709199641BivonaSA26GN80ZSZ135N2026-08-03
10887709199764BivonaXU26GS60NSA218N2026-08-03
10887709199771BivonaFU26GN55NSF216N2026-08-03
10887709199788BivonaXU26GS60NSA217N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709200668BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200675BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200682BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200699BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200705BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200729BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200736BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200767BivonaICU MEDICAL, INC.JOH2026-08-07
10887709200781BivonaICU MEDICAL, INC.JOH2026-08-07
10887709198385BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198866BivonaICU MEDICAL, INC.JOH2026-08-03
10887709198880BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199368BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199580BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199641BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199764BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199771BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199788BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199801BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199818BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199825BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199832BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199849BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199856BivonaICU MEDICAL, INC.JOH2026-08-03
10887709199863BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200002BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200019BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200026BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200033BivonaICU MEDICAL, INC.JOH2026-08-03
10887709200149BivonaICU MEDICAL, INC.JOH2026-08-03