CDSCO UID IMP/MD/2019/000131_ac48dcfd5e97b379b8f9f5b978768108_d643df921032d9e618f1c8f62fe803e4
Tracheostomy Tubes
Smiths Medical India Pvt Ltd·Device Class Class B·India CDSCO·Brand: Portex Blue line Ultra Pediatric Tracheostomy Tube
Registration details
- UID
- IMP/MD/2019/000131_ac48dcfd5e97b379b8f9f5b978768108_d643df921032d9e618f1c8f62fe803e4
- Device class
- Class B
- Brand name
- Portex Blue line Ultra Pediatric Tracheostomy Tube
- License holder
- Smiths Medical India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- Blue Line Ultra® 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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About this record
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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