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Laerdal Pediatric Pocket Mask
EUDAMEDFDA UDIClass I (EU MDR)
Ref 820054Model Paediatric Pocket Mask
Identity
- Trade Name
- Laerdal Pediatric Pocket Mask EUDAMEDPaediatric Pocket Mask w/Gloves & wipe, Polybag FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Paediatric Pocket Mask EUDAMEDThe Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant. FDA UDI
- Model / Reference
- Paediatric Pocket Mask EUDAMED820054 EUDAMEDFDA UDI
- Description
- The Laerdal Paediatric Pocket Mask is a device designed for mouth-to-mask ventilation of a non-breathing child or infant. FDA UDI
Identifiers
- Catalog Number
- 820054 FDA UDI
- Primary DI / UDI-DI
- 07045432001433 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209938T9 EUDAMED
- Direct Marketing DI
- 07045432001433 EUDAMED
- 510(k) Number
- K023805 FDA UDI
- FDA Product Code
- CBP FDA UDI
- EMDN Code
- R03010199 VENTILATION MASKS - OTHER EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, single-use 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
Yes
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
No
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 Pediatric Pocket 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 | 0704543209938T9 | 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 3e6ec292-2170-4641-a8f2-f9a3b27c1042 61 fields · synced Jul 21, 2026
- FDA UDI 9e6d69ec-1fba-4899-8492-61e3e2bbd330 37 fields · synced May 30, 2026