Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Nivairo+ RT057 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version- Small FDA UDI
- Model / Reference
- RT057S FDA UDI
- Description
- Nivairo+ RT057 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version- Small FDA UDI
Identifiers
- Catalog Number
- RT057S FDA UDI
- Primary DI / UDI-DI
- 09420012460752 FDA UDI
- FDA Product Code
- MNT FDA UDI
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CPAP/BPAP face mask, single-use
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as CPAP/BPAP face mask, single-use.
- BiTrac Select — Pulmodyne Inc. · Class II
- Nebulizing Elbow — Respironics, Inc. · Class II
- AF541 — Respironics, Inc. · Class II
- BiTrac SE Select — Pulmodyne Inc. · Class II
- Veraseal 3 Full Face Vented Mask, Small — Sleepnet Corporation · Class II
- Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult — Sleepnet Corporation · Class II
- AF531 — Respironics, Inc. · Class II
- AF531 — 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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI 4b77dacc-3f6c-48ee-88e9-152515c1ec6b 37 fields · synced Jun 6, 2026