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The Dynamed CPR Mask
EUDAMEDFDA UDIClass I (EU MDR)
Ref 820044Model Laerdal Pocket Mask
Identity
- Trade Name
- The Dynamed CPR Mask EUDAMEDDynamed CPR Mask, White FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Laerdal Pocket Mask EUDAMEDThe Dynamed CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant. FDA UDI
- Model / Reference
- Laerdal Pocket Mask EUDAMED820044 EUDAMEDFDA UDI
- Description
- The Dynamed CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant. FDA UDI
Identifiers
- Catalog Number
- 820044 FDA UDI
- Primary DI / UDI-DI
- 07045430043930 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209939TB EUDAMED
- Direct Marketing DI
- 07045430043930 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 I EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Market of Registration
- Norway EUDAMED
- Commercial Distribution
- 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
The Dynamed CPR Mask by Laerdal Medical AS — Class I — 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 | 0704543209939TB | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED 78d96cd9-6ec3-4023-9b5b-9256b84c6955 61 fields · synced Jul 12, 2026
- FDA UDI 49f5e5bd-2085-4c3a-8ad6-b95a6e6f5679 36 fields · synced May 30, 2026