FDA.reportPublic FDA data

Portex

Primary DI
15019315060472
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/899/080
Published
2015-09-01
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
BTOTube, tracheostomy (w/wo connector)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315060476PackageGS11In Commercial Distribution
55019315060470PackageGS17In Commercial Distribution
15019315060472PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931506047635019315060476
5501931506047055019315060470
1501931506047215019315060472

GMDN Terms#

Term, Definition table
TermDefinition
Reinforced tracheostomy tube, single-useA sterile, 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. 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 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
215591523
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
30351688423256Portex008430M2015-09-01
30351688423270Portex008430T2015-09-01
30351688423287Portex008431T2015-09-01
30351688424277Portex0084352015-09-01
30351688404002Portex0020002016-10-05
35019517223334PortexC45101816D-NL2020-06-12
35019517236679PortexC45101817D-NL2020-09-18
30351688403036Portex0077672016-10-05
30351688410249Portex0022202016-12-28
30351688410355Portex0077602016-10-05
30351688416128Portex0022232016-12-28
10351688003782Portex5120702015-07-29
30351688005896Portex5630902015-07-29
10351688017949Portex5120902015-07-29
10351688018670Portex5120602015-07-29
10351688018809Portex5121002015-07-29
30351688018858Portex5630802015-07-29
10351688036674Portex5120802015-07-29
30351688036715Portex5631002015-07-29
10351688037176Portex5020602015-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04035324009114TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010523TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010776TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010837TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010967TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324010981TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011032TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011063TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011124TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011186TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011230TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011247TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011261TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011384TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011407TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011445TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324011827TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012619TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324012718TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013562TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013586TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013678TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013777TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013852TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013876TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324013951TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014026TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014064TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014101TRACOE® comfortTracoe medical GmbHBTO2017-07-03
04035324014132TRACOE® comfortTracoe medical GmbHBTO2017-07-03