Ino Additional Adapters
by Inosystems France EUDAMED
Ref IN000307
EMDN Z1203019080
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number376033338KIT_ADMIN_INOR3 | Date22 Jul 2024 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- NO administration/monitoring kit
- Model / Reference
- IN000307
- Primary DI / UDI-DI
- 03760333380992
- Basic UDI-DI
- 376033338KIT_ADMIN_INOR3
- EMDN Code
- Z1203019080 Various instruments for anaesthesia and pulmonary ventilation support - hardware accessories
- Device Class
- Class IIa
- Medical Purpose
- These kits are intended for the delivery and the sampling / monitoring of gases during iNO therapy performed by a SoKINOX / Monnal iNO device. They contain several elements such as flow sensor, fittings and tubes to adapt to the patient circuit between the ventilator and the patient Y-piece (inspiratory) in order to carry the NO gas to the patient. These kits are for single use only.
Manufacturer details
- EUDAMED SRN
- FR-PR-000018491
Other devices from Inosystems
Properties & raw data
Show properties, registry sources and raw records
Other properties (1)
- Sterile: No
Sources (1)
- EUDAMED e40a2e78-d0a2-41f3-9823-2e4743b9d1fa