Tracheostomy Tubes - India CDSCO Medical Device Registration
Tracheostomy Tubes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2020/000273_ac48dcfd5e97b379b8f9f5b978768108_e0916371d9f4ea5b7d6bbba567f06361. This device is marketed under the brand name Portex. The license holder is SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Portex
Device Class
Approving Authority
CDSCO
Product Information
A sterile range of single use Tracheostomy tubes manufactured from clear biocompatible Polyvinyl Chloride (Portex) incorporating the following features: Smooth arc shaped design with tapered tip to assist placement and removal of both tracheostomy tube and smooth inner cannula with minimal disruption to patient’s anatomy. Thermosensitive material with sufficient initial rigidity for insertion which then conforms to the individual patient’s upper respiratory tract at body temperature ensuring minimum trauma. 15mm connector for connection to anaesthetic or ventilator breathing circuit is located on the tube not the Inner Cannula. Anatomically shaped flexible flange for improved patient comfort and improved security of the Tracheostomy tube. New Profile® Soft-Seal® cuff design with reduced bulk and smooth transition to tracheostomy tube to improve ease of insertion. A hollow obturator with atraumatic tip for use with or without guide wire for improved ease of insertion. The obturator retaining clips prevent obturator movement during insertion. The reusable fenestrated and non fenestrated inner cannulae are colour coded for ease of identification. Fenestrated inner cannulae are coloured red. Non fenestrated inner cannulae are clear. They can be easily inserted and removed from the outer tube with a “ring pull”. Self-adhesive ‘Patient Notes Label’ providing tracheostomy tube size and manufacturing batch details. Tracheostomy Flange Tag’ provides tracheostomy tube size details and indicating if the tube is fenestrated
Decannulation Cap
Brand: Portex
Smiths Medical India Private Limited
Regional Anesthesia Catheter Securement Device
Brand: Portex
Smiths Medical India Private Limited
Tracheostomy Tubes
Brand: Bivona
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Epidural Catheters
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Percutaneous Tracheostomy kit
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Cuff Inflator/ Pressure Gauge
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED
Pressure Monitoring Kits
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Tracheostomy Tubes
Brand: Bivona
Smiths Medical India Private Limited ,Gala 7A & 8A, Ground Floor, Building No. E-3, H No 508, Shree Rajalaxmi Logistics Park, Bhiwandi Nashik Road, Dhamangaon Bhiwandi, Thane - 421302, Maharashtra, India. ,Thane Maharashtra ,421302 ,India
Nasopharyngeal Airway
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Orator- Tracheostomy speaking valve
Brand: Portex
SMITHS MEDICAL INDIA PRIVATE LIMITED ,GALA 4B,5B,6B,7, 8, 9 & 10, GR FL, BLDG E-3, SHREE KALKI LOG SHREE RAJLAXMI LOGISTICS PARK, OLD BHIWANDI-AGRA ROAD, DHAMANGAON - 421302, Taluka BHIWANDI - 16, District THANE Z5 ,Thane Maharashtra ,421302 ,India
Arterial Blood sampling
Brand: Pro-Vent, Line-Draw
Tracheostomy Tubes
Brand: Bivona
Inner cannula
Brand: Bivona
High flow Nasal Cannula
Brand: Infant
High Flow Nasal Cannula
Brand: Infant
Epidural Catheters
Brand: Portex
Percutaneous Tracheostomy kit
Brand: Portex
Pressure Monitoring Kits
Brand: Portex
Percutaneous Tracheostomy Kit
Brand: Ultraperc