Laerdal Silicone Resuscitator
by Laerdal Medical AS EUDAMED
Active
Ref 85005340, 87005157, 86005500, 87005100, 870702, 85005333, 87005500, 86005300, 851103Model LSR Complete w/Masks, Laerdal Silicone Resuscitator
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0704543209968TJ | Date10 Nov 2022 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
European Union — CE/MDR Active
Specification
- Model / Reference
- LSR Complete w/Masks, 85005340, 87005157, 86005500, 87005100, Laerdal Silicone Resuscitator, 870702, 85005333, 87005500, 86005300, 851103
- Primary DI / UDI-DI
- 07045432076189, 07045432101546, 07045430045316, 07045430046153, 07045430076976, 07045432076172, 07045430046252, 07045430045279, 07045430012219
- Basic UDI-DI
- 0704543209968TJ, 0704543209945T6
- Direct Marketing DI
- 0704543007697607045430012219
- EMDN Code
- R03020199, R030280
- Device Class
- Class IIa
- Market of Registration
- Norway
- Medical Purpose
- The Laerdal Silicone Resuscitator (LSR) is intended for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The Laerdal Silicone Resuscitator is available in three sizes: • The Adult model is intended for patients over 25 kg (44 lb). • The Paediatric model is intended for patients from 2.5 kg (5.5 lb) to 25 kg (44 lb). • The Preterm model is intended for patients below 2.5 kg (5.5 lb).
Manufacturer details
- EUDAMED SRN
- NO-PR-000002650
Other devices from Laerdal Medical AS
Properties
Other properties (13)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No