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Laerdal Silicone Resuscitator
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 86005633Model LSR Complete w/Masks
Identity
- Trade Name
- Laerdal Silicone Resuscitator EUDAMEDLSR Paedi. Std. Term w/Mask in Carton (IE 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 pati - ents over 25 kg (55 lb). FDA UDI
- Model / Reference
- LSR Complete w/Masks EUDAMED86005633 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 pati - ents over 25 kg (55 lb). FDA UDI
Identifiers
- Catalog Number
- 86005633 FDA UDI
- Primary DI / UDI-DI
- 07045430045347 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
- 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 688c24b9-6fec-4c6e-a1f3-b2977a441afc 61 fields · synced Aug 2, 2026
- FDA UDI 28e30819-0bdc-4107-9a93-02e304ae4bfc 36 fields · synced May 30, 2026