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Laerdal Silicone Resuscitators
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 86005000Model Laerdal Silicone ResuscitatorRef 87995000Ref 86995233Ref 87005000
Identity
- Trade Name
- Laerdal Silicone Resuscitators EUDAMEDLSR Paediatric Std.w/Mask 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 pati - ents over 25 kg (55 lb). FDA UDI
- Model / Reference
- Laerdal Silicone Resuscitator EUDAMED86005000 EUDAMED87995000 EUDAMED86995233 EUDAMEDFDA UDI87005000 EUDAMED
- 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
- 86995233 FDA UDI
- Primary DI / UDI-DI
- 07045430045187 EUDAMED07045430046689 EUDAMED07045430045903 EUDAMEDFDA UDI07045430046122 EUDAMED
- Basic UDI-DI
- 0704543209945T6 EUDAMED
- Direct Marketing DI
- 07045430045187 EUDAMED07045430046689 EUDAMED07045430045903 EUDAMED07045430046122 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
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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 Resuscitators 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 | 0704543209945T6 | 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-MF-000000012
Sources (5)
- EUDAMED b3e71455-8803-4c60-8423-5d0098cce734 61 fields · synced Oct 6, 2026
- EUDAMED 4de79110-6691-4f4e-a318-14ced82914ee 61 fields · synced May 17, 2026
- EUDAMED 27959211-befa-4182-878f-7ac8243ad158 61 fields · synced May 17, 2026
- EUDAMED 8ec3bb0f-7a20-4526-bcb0-2648f83cee01 61 fields · synced May 18, 2026
- FDA UDI a90c79f3-aca6-429a-829b-c5e11ceb8f30 37 fields · synced May 30, 2026