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The Pocket Mask with Oxygen Inlet
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 83001933Model Pocket Mask with Oxygen Inlet
Identity
- Trade Name
- The Pocket Mask with Oxygen Inlet EUDAMEDPocket Mask O2 w/o wipe & gloves HC (IE) FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Pocket Mask with Oxygen Inlet EUDAMEDThe Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
- Model / Reference
- Pocket Mask with Oxygen Inlet EUDAMED83001933 EUDAMEDFDA UDI
- Description
- The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
Identifiers
- Catalog Number
- 83001933 FDA UDI
- Primary DI / UDI-DI
- 07045432040418 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209940SU EUDAMED
- Direct Marketing DI
- 07045432040418 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
- 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 Pocket Mask with Oxygen Inlet 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 | 0704543209940SU | 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 (2)
- EUDAMED 9307ab4c-485f-4eda-a548-10ca8d61baec 61 fields · synced Aug 2, 2026
- FDA UDI 429e5d00-3956-4e62-84a0-b26f26da4ce8 36 fields · synced May 30, 2026