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Laerdal Face Shield
EUDAMEDFDA UDIClass I (EU MDR)
Ref 460008Model Laerdal Face Shield
Identity
- Trade Name
- Laerdal Face Shield EUDAMEDKeyring w/LFS x 25 Yellow. FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- Laerdal Face Shield EUDAMEDThe Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients. Its hydrophobic filter gives the user and the victim effective protection. It is available in a convenient sealed key ring. FDA UDI
- Model / Reference
- Laerdal Face Shield EUDAMED460008 EUDAMEDFDA UDI
- Description
- The Laerdal Face Shield (LFS) is a single use medical device intended as a CPR barrier between a rescuer and a patient and to aid rescuers trained in resuscitation, in mouth-to-mouth resuscitation of non-breathing patients. Its hydrophobic filter gives the user and the victim effective protection. It is available in a convenient sealed key ring. FDA UDI
Identifiers
- Catalog Number
- 460008 FDA UDI
- Primary DI / UDI-DI
- 07045430040465 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209941SW EUDAMED
- Direct Marketing DI
- 07045430040465 EUDAMED
- 510(k) Number
- K880450 FDA UDI
- FDA Product Code
- BTM 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
- 868.5915 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
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 Face Shield 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 | 0704543209941SW | 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 de7309f6-a718-4506-9667-a08810ef3b34 61 fields · synced May 30, 2026
- FDA UDI c9e67d94-e177-4a89-928d-965d982f5d20 37 fields · synced May 24, 2026