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Laerdal Silicone Masks
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 865200Model Laerdal Silicone Mask Ref 870221
Identity
- Trade Name
- Laerdal Silicone Masks EUDAMEDAdult Silicone Mask 4-5+ w/o Multi-Func Mask Cover FDA UDI
- Generic Name
- Resuscitator face mask, reusable FDA UDI
- Device Name
- Laerdal Silicone Mask EUDAMEDLaerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient. FDA UDI
- Model / Reference
- Laerdal Silicone Mask EUDAMED865200 EUDAMED870221 EUDAMEDFDA UDI
- Description
- Laerdal Silicone Masks are intended to be used for ventilation of patients. The multi-function Mask Cover is intended to be used to add additional support, when needed, to Laerdal Silisone Masks (sizes 3-4, 4-5+) and to allow for strapping of Laerdal Silicone Masks to the patient. FDA UDI
Identifiers
- Catalog Number
- 870221 FDA UDI
- Primary DI / UDI-DI
- 07045430012424 EUDAMED07045432033946 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209946T8 EUDAMED
- Direct Marketing DI
- 07045430012424 EUDAMED07045432033946 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R030180 RESPIRATORY MASKS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES EUDAMEDR03010199 VENTILATION MASKS - OTHER EUDAMED
- GMDN Term
- Resuscitator face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 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
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 Masks 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 | 0704543209946T8 | 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 (3)
- EUDAMED c80e8799-0d36-4df6-aad4-d5a01348b8f1 61 fields · synced Oct 6, 2026
- EUDAMED 9f3569bb-b304-4521-a1b2-9cc9d86c5b4c 61 fields · synced May 17, 2026
- FDA UDI 7615a367-df51-41d4-98d3-ef21214c6692 36 fields · synced May 30, 2026