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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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Class Class B
Tracheostomy Tubes
UID: IMP/MD/2019/000131_ac48dcfd5e97b379b8f9f5b978768108_d643df921032d9e618f1c8f62fe803e4

Brand Name

Portex Blue line Ultra Pediatric Tracheostomy Tube

Device Class

Class B

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.

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