FDA.reportPublic FDA data

Portex

Primary DI
35019315059562
Brand
Portex
Company
Smiths Medical International Ltd
Model
100/189/090
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
NTRIMMUNOHISTOCHEMICAL REAGENT, ANTIBODY (MONOCLONAL OR POLYCLONAL) TO P63 PROTEIN IN NUCLEUS OF PROSTATIC BASAL CELLS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTRImmunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal CellsHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081086000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081086000PORTEX BLUE LINE SACETT SUCTION ABOVE THE CUFF TRACHEAL TUBE, SIZE 6.0 AND 6.5, 7.0 AND 7.5, 8.0 AND 8.5, 9.0Smiths Medical Asd, Inc.2008-08-13BTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
35019315059562PackageGS110In Commercial Distribution
55019315059566PackageGS112In Commercial Distribution
15019315059568PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3501931505956235019315059562
5501931505956655019315059566
1501931505956815019315059568

GMDN Terms#

Term, Definition table
TermDefinition
Cuff-suction endotracheal tubeA hollow cylinder inserted orally into the trachea to maintain airway patency, typically for patients anticipated to require prolonged mechanical ventilation in critical care, that enables removal of pooled secretion above its distal cuff with suction. It consists of a ventilation lumen, a cuff-inflation lumen, and a suction lumen; a distal inflatable cuff used to form a seal against the tracheal wall; separate connectors that attach to a breathing circuit and suction system; and a pilot balloon for cuff-pressure monitoring. It typically has a radiopaque marker to guide its placement and is available in various diameters/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
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
30351688005896Portex5630902015-07-29
30351688018858Portex5630802015-07-29
30351688036715Portex5631002015-07-29
30351688041122Portex5260602015-07-29
30351688041139Portex5260702015-07-29
50351688041140Portex5260802015-07-29
30351688041153Portex5260902015-07-29
35019315052617Portex100/856/0752015-09-01
30351688415510Portex225-3524-8042016-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00673693107716Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107723Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107839Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693107846Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108034Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108676Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108683Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108836Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693108843Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693194723Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693195805Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693196260Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693363792Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693363808Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367530Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367547Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367554Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693367561Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693373982Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693376419Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693376426Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386463Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386937Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693386944Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693559195Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693559560Thermo ScientificRICHARD-ALLAN SCIENTIFIC COMPANYNTR2022-06-20
00673693180375Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180382Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180399Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09
00673693180405Thermo Scientific RICHARD-ALLAN SCIENTIFIC COMPANYNTR2018-04-09