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CDSCO UID IMP/MD/2018/000148_ac48dcfd5e97b379b8f9f5b978768108_0f57e3a4cb05e62f7744f1fb91e4f004

Tracheostomy Tubes

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·Device Class Class C·India CDSCO·Brand: Shiley
Registration details
UID
IMP/MD/2018/000148_ac48dcfd5e97b379b8f9f5b978768108_0f57e3a4cb05e62f7744f1fb91e4f004
Device class
Class C
Brand name
Shiley
License holder
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
Approving authority
CDSCO
Product information
The Shiley range of Tracheostomy Tubes are indicated for use in airway management in conjunction with a medical need to perform a tracheotomy.Certain circumstances will sometimes require special features which are described below. One product could have more than one special feature. Indications Lanz: Where intra-cuff pressure is critical, over prolonged periods of placement, the Lanz Pressure Regulating Valve is indicated. Indications EVAC: Where profuse secretions build up above the cuff or tracheal infection needs to be minimized, the EVAC lumen versions are indicated. Indications Pitt : Where it is desired that the patient has a degree of speech, the PITT Speaking Tube is indicated.
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About this record

Tracheostomy Tubes is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2018/000148_ac48dcfd5e97b379b8f9f5b978768108_0f57e3a4cb05e62f7744f1fb91e4f004. This device is marketed under the brand name Shiley. The license holder is 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, and it is classified as Device Class Class C. The approving authority is CDSCO.

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