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Newborn Mask
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref LGH-84615601Model Newborn Mask
Identity
- Trade Name
- Newborn Mask EUDAMEDNewborn Mask - Size 0 Qty 10 - Snap Design (US) FDA UDI
- Generic Name
- Resuscitator face mask, reusable FDA UDI
- Device Name
- Newborn Mask EUDAMEDNewborn Masks are intended for face mask ventilation of newborns and infants. FDA UDI
- Model / Reference
- Newborn Mask EUDAMEDLGH-84615601 EUDAMEDFDA UDI
- Description
- Newborn Masks are intended for face mask ventilation of newborns and infants. FDA UDI
Identifiers
- Catalog Number
- LGH-84615601 FDA UDI
- Primary DI / UDI-DI
- 07045432092448 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209949TE EUDAMED
- Direct Marketing DI
- 07045432092448 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R03010199 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
Moist Heat or Steam Sterilization FDA UDI
Newborn Mask 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 | 0704543209949TE | 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 4b74d3e7-7db6-47fc-915c-3f95ad881d16 61 fields · synced Jul 10, 2026
- FDA UDI f5701e3d-bc1d-48ed-9ce1-7fb1792f8424 36 fields · synced May 30, 2026