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/2018/000356_ac48dcfd5e97b379b8f9f5b978768108_606f5bca7e56d98d238fcb1e927702ed. This device is marketed under the brand name Blue line Ultra. 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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CDSCO Registered

Class Class B

Tracheostomy Tubes

UID: IMP/MD/2018/000356_ac48dcfd5e97b379b8f9f5b978768108_606f5bca7e56d98d238fcb1e927702ed

Brand Name

Blue line Ultra

License Holder

Smiths Medical India Pvt Ltd

Device Class

Class B

Approving Authority

CDSCO

Product Information

A sterile range of single use Tracheostomy tubes manufactured from clear biocompatible Polyvinyl Chloride (Blue line Ultra) 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

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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 - India CDSCO Medical Device Registration

Brand Name

License Holder

Device Class

Approving Authority

Product Information

DJ Fang

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