CDSCO UID IMP/MD/2021/000505_d6316b5368e04a72e99e8fd4c842ccb7_7abc296d8c7e9ff5d0148cc4f8c11b53
Bubble CPAP Delivery System
Fisher & Paykel Healthcare India Pvt Ltd·Device Class Class C·India CDSCO
Registration details
- UID
- IMP/MD/2021/000505_d6316b5368e04a72e99e8fd4c842ccb7_7abc296d8c7e9ff5d0148cc4f8c11b53
- Device class
- Class C
- License holder
- Fisher & Paykel Healthcare India Pvt Ltd
- Approving authority
- CDSCO
- Product information
- The Fisher & Paykel Healthcare Bubble CPAP System is intended to provide CPAP to spontaneously breathing neonates and infants who require breathing support due to conditions associated with prematurity ##PLACEHOLDER_0## or other conditions where CPAP is required or desired and is prescribed by a physician. The Bubble CPAP System is for use in the hospital clinical environment such as the NICU ##PLACEHOLDER_0## and PICU ##PLACEHOLDER_0##. The intended patient population is premature and full term neonates up to a weights of 10kg.
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About this record
Bubble CPAP Delivery System is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2021/000505_d6316b5368e04a72e99e8fd4c842ccb7_7abc296d8c7e9ff5d0148cc4f8c11b53. The license holder is Fisher & Paykel Healthcare India Pvt Ltd, and it is classified as Device Class Class C. The approving authority is CDSCO.
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