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Laerdal Silicone Resuscitator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 85995133Model LSR Complete w/Masks
Identity
- Trade Name
- Laerdal Silicone Resuscitator EUDAMEDLSR Preterm Cpl. w/Masks in Carton (IE) PL FDA UDI
- Generic Name
- Pulmonary resuscitator, manual, reusable FDA UDI
- Device Name
- Laerdal Silicone Resuscitator EUDAMEDThe Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support. The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) face - mask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for patients over 25 kg (55 lb). FDA UDI
- Model / Reference
- LSR Complete w/Masks EUDAMED85995133 EUDAMEDFDA UDI
- Description
- The Laerdal Silicone Resuscitator is a self-inflating manual resuscitator that is intended for patients requiring total or intermittent ventilatory support. The Laerdal Silicone Resuscitator provides positive pressure ventilation and allows spontaneous breathing either with a 22 mm ID (inner diameter) face - mask port, through an artificial airway or with a facemask that has a 15 mm OD (outer diameter) connection. The Preterm model is intended for patients below 2,5 kg (5,5 lb), the Paediatric model is intended for patients from 2,5 (5,5 lb) to 25 kg (55 lb), and the Adult model is intended for patients over 25 kg (55 lb). FDA UDI
Identifiers
- Catalog Number
- 85995133 FDA UDI
- Primary DI / UDI-DI
- 07045430045033 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209968TJ EUDAMED
- FDA Product Code
- BTM FDA UDI
- EMDN Code
- R03020199 VENTILATION BALLOONS - OTHER EUDAMED
- GMDN Term
- Pulmonary resuscitator, manual, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5915 FDA UDI
- 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). EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Laerdal Silicone Resuscitator by Laerdal Medical AS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0704543209968TJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-PR-000002650
Sources (2)
- EUDAMED 2597860f-ab05-460e-8bf9-695b06054c97 61 fields · synced Jun 18, 2026
- FDA UDI 72feecdb-5a4a-49ee-bbd5-351a42c21550 37 fields · synced May 30, 2026