FDA.reportPublic FDA data

Portex

Primary DI
55019315104846
Brand
Portex
Company
Smiths Medical Czech Republic a.s.
Model
100/870/070CZ
Published
2020-03-12
Public version status
New
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
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTOTube, Tracheostomy (W/Wo Connector)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030570000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030570000BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBEPortex , Ltd.2003-09-17BTO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315104842PackageGS11In Commercial Distribution
55019315104846PackageGS126In Commercial Distribution
15019315104848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931510484235019315104842
5501931510484655019315104846
1501931510484815019315104848

GMDN Terms#

Term, Definition table
TermDefinition
Basic tracheostomy tube, single-useA sterile 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 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 to meet the individual needs of the patient. 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
361330253
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
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
35019315107287Portex100/386/010CZ2020-06-22
35019315104835Portex100/870/060CZ2020-03-12
35019315104859Portex100/870/075CZ2020-03-12
35019315104866Portex100/870/080CZ2020-03-12
35019315104873Portex100/870/085CZ2020-03-12
35019315104880Portex100/870/090CZ2020-03-12
55019315103016Portex100/597/070CZ2016-04-04
55019315106604Portex100/541/080CZ2016-04-04
35019315106617Portex100/541/090CZ2016-04-04
35019315106662Portex100/541/070CZ2016-04-04
35019315106754Portex100/562/000CZ2016-04-04
55019315107144Portex100/597/080CZ2016-04-04
55019315106888Portex100/891/080CZ2016-04-04
35019315106891Portex100/891/090CZ2016-04-04
35019315106907Portex100/892/200CZ2016-04-05
35019315107157Portex100/597/090CZ2016-04-04
55019315107199Portex100/897/070CZ2016-04-04
35019315107201Portex100/897/080CZ2016-04-04
55019315107229Portex100/899/070CZ2016-04-04
55019315107236Portex100/899/080CZ2016-04-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00348783010640Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010657Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010664Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010671Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010695Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010701Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010718Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010725Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010732Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010749Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010756Premier Jackson Original Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010770Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010787Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010794Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010800Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010817Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010824Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010831Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010848Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010855Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010862Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010879Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010886Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010893Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010909Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010916Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010923Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010930Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010947Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09
00348783010954Premier Jackson Improved Tracheostomy TubePREMIER DENTAL PRODUCTS COMPANYBTO2026-06-09