Identity
- Trade Name
- NV QUATTRO AIR FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- NV QUATTRO AIR FFM SML FDA UDI
- Model / Reference
- 62779 FDA UDI
- Description
- NV QUATTRO AIR FFM SML FDA UDI
Identifiers
- Catalog Number
- 62779 FDA UDI
- Primary DI / UDI-DI
- 00619498627790 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- CPAP/BPAP face mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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: CPAP/BPAP face mask, reusable
Nv Quattro Air by Resmed Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP face mask, reusable.
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- AIRFIT F20 — Resmed Corp · Class II
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- Fisher & Paykel Healthcare — FISHER & PAYKEL HEALTHCARE, INC. · Class II
- Amara View — Respironics, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Resmed Pty Ltd
Sources (1)
- FDA UDI 86fd2321-ab52-4901-9473-51a85cd8402d 36 fields · synced Jun 1, 2026