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/2019/000131_ac48dcfd5e97b379b8f9f5b978768108_d643df921032d9e618f1c8f62fe803e4. This device is marketed under the brand name Portex Blue line Ultra Pediatric Tracheostomy Tube . The license holder is Smiths Medical India Pvt Ltd, and it is classified as Device Class Class B. The approving authority is CDSCO.
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Brand Name
Portex Blue line Ultra Pediatric Tracheostomy Tube
License Holder
Smiths Medical India Pvt LtdDevice Class
Approving Authority
CDSCO
Product Information
Blue Line Ultraยฎ Paediatric Tracheostomy tube is intended for paediatric patients that require an artificial airway due to trauma or medical condition and is used in patients that are either spontaneously breathing or require mechanical ventilation; allowing access to the trachea for suctioning. Maximum recommended period of use is 29 days. This device is intended for use in the paediatric patient population born at gestational age greater than 37 weeks and not in the neonatal developmental stage. This device is NOT intended for preterm and neonatal population. The neonatal developmental stage is the 28 days following birth.
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
Tracheostomy Tubes
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
Tracheostomy Tubes
Brand: Portex
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
Tracheostomy Tubes
Brand: Blue line Ultra
Smiths Medical India Pvt Ltd
Tracheostomy Tubes
Brand: Portex
Smiths Medical India Pvt Ltd
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
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
Tracheostomy Tubes
Brand: Shiley
India Medtronic Private Limited ,Shed No. 3, Block No. 1, Survey No. 389, 400/2A & 2C, Pudur Main Road, Kuthambakkam - 600124, Poonamallee Taluk, Tiruvallur District ,Tiruvallur Tamil Nadu ,600124 ,India
Central Venous Catheters
Percutaneous Tracheostomy Kit
Brand: Ultraperc
Epidural Catheters
Brand: Blue line Ultra
Percutaneous Tracheostomy kit
Brand: Blue line Ultra
Tracheostomy Tubes
Brand: Blue line Ultra
Pressure Monitoring Kits
Brand: Blue line Ultra
SuctionPro 72 closed suction catheter
Brand: Portex
Endobronchial tubes
Brand: Portex
Tracheostomy Tubes
Brand: Portex
Endotracheal Tube
Brand: Portex

