Portex - 100/189/090
Device Description
A 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.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: True
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NTR
Device Name: Immunohistochemical Reagent, Antibody (Monoclonal Or Polyclonal) To P63 Protein In Nucleus Of Prostatic Basal Cells
Device Class: 1
Physical State: N/A
Definition: MONOCLONAL OR POLYCLONAL ANTIBODY THAT RECOGNIZES THE HUMAN P63 PROTEIN IN THE NUCLEUS OF PROSTATIC BASAL CELLS USING ROUTINE IMMUNOHISTOCHEMICAL TECHNIQUES, INCLUDING HEAT-INDUCED ANTIGEN EPITOPE RETRIEVAL. THIS TEST IS INTENDED FOR LABORATORY USE TO QUALITATIVELY IDENTIFY THE P63 ANTIGEN IN HISTOLOGICAL SECTIONS FROM FORMALIN-FIXED PARAFFIN-EMBEDDED SAMPLES OF NORMAL AND/OR PATHOLOGICAL PROSTATE TISSUE OBTAINED BY NEEDLE BIOPSY OR SURGICAL PROCEDURES. THE PRESENCE OR ABSENCE OF P63 STAINING AIDS THE PATHOLOGIST IN THE DIFFERENTIAL DIAGNOSIS OF PROSTATE CANCER IN CONJUNCTION WITH MORPHOLOGICAL FINDINGS SEEN WITH HEMATOXYLIN AND EOSIN STAINING COMPLEMENTED BY PROPER CONTROLS.
Submission Type ID: 4
Review Panel: PA
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 864.1860
Third Party Flag: N
Medical Specialty: HE
Device IdentifiersDevice Id: 35019315059562
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 15019315059568
Package Quantity: 10
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Box
Device Id: 15019315059568
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 55019315059566
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 35019315059562
Package Quantity: 12
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: Case