FDA.reportPublic FDA data

Portex

Primary DI
10351688001481
Brand
Portex
Company
ICU MEDICAL, INC.
Model
513060
Published
2015-07-29
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
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K934465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K934465000DIC TRACHEOSTOMY TUBE AND PORTEX BLUE LINESmiths Industries Medical Systems, Inc.1994-01-14BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10351688001481PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1035168800148110351688001481

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10887709199801BivonaFU25GN65NSD167N2026-08-03
10887709199818BivonaSU26GN50NGF219N2026-08-03
10887709199825BivonaFU26GN45NSC211N2026-08-03
10887709199832BivonaFU26GN45NGF214N2026-08-03
10887709199849BivonaFU26GN35NSE226N2026-08-03
10887709199856BivonaFU26GN30NSE227N2026-08-03
10887709199863BivonaFT26GN40NSC233N2026-08-03
10887709200002BivonaFU26GN45NSF240N2026-08-03
10887709200019BivonaFT26GN55NGF246N2026-08-03
10887709200026BivonaFU26GN30NGA239N2026-08-03
10887709200033BivonaST26GN55NSC245N2026-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
14026704934758LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934765LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934772LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704934802LMA AIRWAY MANAGEMENTTELEFLEX INCORPORATEDBTR2026-08-03
14026704759191SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759399SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759405SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759412SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759429SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759436SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759443SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759481SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759498SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759504SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759511SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759566SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759573SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759597SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759696SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759740SHERIDANTELEFLEX INCORPORATEDBTR2026-08-01
14026704759580SHERIDANTELEFLEX INCORPORATEDBTR2026-07-29
00810003750822KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750839KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750846KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750853ENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750860KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750877KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750884KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750891KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08
00810003750907KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-08