FDA.reportPublic FDA data

Portex

Primary DI
35019517103544
Brand
Portex
Company
SMITHS MEDICAL ASD, INC.
Model
101/892/080
Published
2019-12-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
K173912000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173912000BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tubeSmiths Medical Asd, Inc.2018-05-08JOH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019517103544PackageGS15In Commercial Distribution
15019517103540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501951710354435019517103544
1501951710354015019517103540

GMDN Terms#

Term, Definition table
TermDefinition
Tracheostomy kit, single-useA collection of sterile surgical instruments, dressings/swabs, syringe, dilators, tracheostomy tubes and other items intended to be used to create a percutaneous opening in the trachea (tracheotomy) for the insertion of a tracheostomy tube to relieve upper airway obstruction and to facilitate ventilation. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
137835299
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50351688508896MedexMX207752016-10-11
50351688508933MedexMX207552016-10-11
50610674800094PortexH4003PS2015-09-01
30610674802094PortexH4021PS2015-09-01
30610674802780PortexH4022PS2015-09-01
50351688500302MedexTF562016-10-13
50351688500319MedexTF552016-12-29
50351688500487MedexSM7223SC2016-10-13
50351688500555MedexSM50142017-01-03
50351688500647MedexSM50042017-01-03
50351688500654MedexSM50032017-01-03
50351688504638MedexMX8702016-10-13
50351688505031MedexMX8012016-10-13
50351688505406MedexMX7452017-02-27
50351688505413MedexMX7432016-10-13
50351688506878MedexMX4982016-10-12
50351688506922MedexMX4922016-10-12
50351688507097MedexMX457L2016-10-12
50351688507103MedexMX4572016-10-12
50351688507189MedexMX453L2016-10-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10887709203263BivonaICU MEDICAL, INC.JOH2026-09-04
10887709203270BivonaICU MEDICAL, INC.JOH2026-09-04
10887709203287BivonaICU MEDICAL, INC.JOH2026-09-04
10887709203294BivonaICU MEDICAL, INC.JOH2026-09-04
10887709203300BivonaICU MEDICAL, INC.JOH2026-09-04
10887709203324BivonaICU MEDICAL, INC.JOH2026-09-04
10887709201641BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202174BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202426BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202433BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202440BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202464BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202471BivonaICU MEDICAL, INC.JOH2026-08-27
10887709202259BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202266BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202273BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202280BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202297BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202303BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202310BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202327BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202334BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202341BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202358BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202365BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202372BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202389BivonaICU MEDICAL, INC.JOH2026-08-26
10887709202396BivonaICU MEDICAL, INC.JOH2026-08-26
10887709200071BivonaICU MEDICAL, INC.JOH2026-08-25
10887709201658BivonaICU MEDICAL, INC.JOH2026-08-25