FDA.reportPublic FDA data

Portex

Primary DI
55019315054110
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/166/085
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
BTRTube, tracheal (w/wo connector)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315054116PackageGS110In Commercial Distribution
55019315054110PackageGS112In Commercial Distribution
15019315054112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505411635019315054116
5501931505411055019315054110
1501931505411215019315054112

GMDN Terms#

Term, Definition table
TermDefinition
Basic endotracheal tube, single-useA hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring. It is typically made of plastic or rubber and is available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
215591523
Device count
1
DM exempt
false
Premarket exempt
true
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
24026704941043SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941057SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941064SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941074SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941081SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941095SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941101SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941118SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
24026704941128SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941132SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
34026704941149SHERIDANTELEFLEX INCORPORATEDBTR2025-12-11
44026704617195TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617201TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617211TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
34026704617235TELEFLEXTELEFLEX INCORPORATEDBTR2025-11-20
44026704617911HUDSON RCITELEFLEX INCORPORATEDBTR2025-11-20
34026704930976SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930983SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704930990SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931006SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931013SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931027SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
24026704931037SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931041SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931058SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
34026704931065SHERIDANTELEFLEX INCORPORATEDBTR2025-06-10
05055788776246ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776260ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776284ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30
05055788776307ProVu Video StyletFLEXICARE MEDICAL LIMITEDBTR2025-05-30