CDSCO UID IMP/MD/2023/001172_e4065371af6b96bf9d9a01a007d854b6_7574be06831ade7185c09a9888e251a8
Syringe
M/s. Hansraj Nayyar Medical India·Device Class Class B·India CDSCO·Brand: Sedaconda®
Registration details
- UID
- IMP/MD/2023/001172_e4065371af6b96bf9d9a01a007d854b6_7574be06831ade7185c09a9888e251a8
- Device class
- Class B
- Brand name
- Sedaconda®
- License holder
- M/s. Hansraj Nayyar Medical India
- Approving authority
- CDSCO
- Product information
- The Sedaconda® syringe is intended to deliver liquid volatile anaesthetic to the Sedaconda® ACD devices. The device is single use only. The syringe can be used with syringe pumps which comply with ISO 60601-2-24.
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Anaesthetic Delivery System- Sedaconda® ACD is intended for administering isoflurane and sevoflurane to invasively ventilated patients. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Sedaconda® ACD is intended for single use only and needs to be replaced every 24 hours or when needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc. The Sedaconda® ACD is available in Sedaconda® ACD 100 ml and Sedaconda® ACD 50 ml sizes. The instructions contained in this document apply to both devices. Sedaconda® ACD for Small Tidal Volumes and the connection of the Sedaconda® ACD to the inspiratory port of the ventilator. This placement is intended for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30
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Anaesthetic Delivery System- Sedaconda® ACD is intended for administering isoflurane and sevoflurane to invasively ventilated patients. Administration of isoflurane and sevoflurane using Sedaconda® ACD should only be done in a setting fully equipped for the monitoring and support of respiratory and cardiovascular function and by persons specifically trained in the use of inhalational anaesthetic drugs and the recognition and management of the expected adverse effects of such drugs, including respiratory and cardiac resuscitation. Such training must include the establishment and maintenance of a patent airway and assisted ventilation. Sedaconda® ACD is intended for single use only and needs to be replaced every 24 hours or when needed e.g. at unexpected events such as sudden blockage of the airways because of secretion etc. The Sedaconda® ACD is available in Sedaconda® ACD 100 ml and Sedaconda® ACD 50 ml sizes. The instructions contained in this document apply to both devices. Sedaconda® ACD for Small Tidal Volumes and the connection of the Sedaconda® ACD to the inspiratory port of the ventilator. This placement is intended for and enables the delivery of inhaled anaesthetics to patients with tidal volumes of 30
Brand: Sedaconda®
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About this record
Syringe is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/001172_e4065371af6b96bf9d9a01a007d854b6_7574be06831ade7185c09a9888e251a8. This device is marketed under the brand name Sedaconda®. The license holder is M/s. Hansraj Nayyar Medical India, and it is classified as Device Class Class B. The approving authority is CDSCO.
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