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Laerdal Pocket Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 83004033Model Pocket Mask with Oxygen
Identity
- Trade Name
- Laerdal Pocket Mask EUDAMEDPocket Mask w/O2,SP (Blue, IE) FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Laerdal Pocket Mask EUDAMEDThe Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
- Model / Reference
- Pocket Mask with Oxygen EUDAMED83004033 EUDAMEDFDA UDI
- Description
- The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
Identifiers
- Catalog Number
- 83004033 FDA UDI
- Primary DI / UDI-DI
- 07045430044500 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209951SZ EUDAMED
- FDA Product Code
- CBP FDA UDI
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Medical Purpose
- The Pocket Mask with Oxygen Inlet is designed for mouth-to-mask ventilation of a non-breathing adult as a barrier between the rescuer and patient. The Pocket Mask with Oxygen Inlet can be connected to an external Oxygen source 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Laerdal Pocket Mask 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 | 0704543209951SZ | 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 1b5c15fb-d196-45e7-bfc3-4ae5306eda16 61 fields · synced Oct 6, 2026
- FDA UDI c1a80710-cd51-4c51-94ee-351ffe491e47 36 fields · synced May 24, 2026