Identity
- Trade Name
- NV Quattro Air FFM LGE - EUR EUDAMEDNV QUATTRO AIR FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Quattro Air NV EUDAMEDNV QUATTRO AIR FFM LGE FDA UDI
- Model / Reference
- 62785 EUDAMEDFDA UDI
- Description
- NV QUATTRO AIR FFM LGE FDA UDI
Identifiers
- Catalog Number
- 62785 FDA UDI
- Primary DI / UDI-DI
- 00619498627851 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC1476P EUDAMED
- Direct Marketing DI
- 00619498003570 EUDAMED
- FDA Product Code
- BYG FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Market of Registration
- Netherlands 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
Category: Rebreathing oxygen face mask
NV Quattro Air FFM LGE - EUR by Resmed Pty Ltd — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Rebreathing oxygen face mask.
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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 | 619498EC1476P | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (2)
- EUDAMED b84491fa-fcfd-4c6d-bb7a-da8492fe5c63 61 fields · synced Jun 18, 2026
- FDA UDI 57d4cb3b-d78c-4007-9860-9fa62f3db37e 36 fields · synced May 30, 2026