← Back to catalogue
NV Quattro Air FFM XSML - EUR
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 62782
Identity
- Trade Name
- NV Quattro Air FFM XSML - EUR EUDAMEDNV QUATTRO AIR FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- Quattro Air NV EUDAMEDNV QUATTRO AIR FFM XSML FDA UDI
- Model / Reference
- 62782 EUDAMEDFDA UDI
- Description
- NV QUATTRO AIR FFM XSML FDA UDI
Identifiers
- Catalog Number
- 62782 FDA UDI
- Primary DI / UDI-DI
- 00619498627820 EUDAMEDFDA UDI
- Basic UDI-DI
- 619498EC1476P EUDAMED
- Direct Marketing DI
- 00619498003662 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 XSML - EUR by Resmed Pty Ltd — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Similar devices
Also classified as Rebreathing oxygen face mask.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- Ventlab — Ventlab Corp. · Class I
- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123979 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 619498EC1476P | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- ResMed PTY LTD
- EUDAMED SRN
- AU-MF-000011753
- Authorised Representative
- ResMed SAS FR-AR-000007151
Sources (3)
- EUDAMED 6235a2e6-cc32-4681-bdd6-a043f889c5e9 61 fields · synced Jun 18, 2026
- FDA UDI 185b0923-f32c-4b26-854b-a643c517b130 36 fields · synced May 30, 2026
- FDA 510(k) K123979 1 fields · synced May 18, 2026