Identity
- Trade Name
- Fisher & Paykel Healthcare FDA UDI
- Generic Name
- Professional BPAP/high-flow respiratory unit FDA UDI
- Device Name
- Airvo 3 NIV Respiratory Support Device FDA UDI
- Model / Reference
- PT311US FDA UDI
- Description
- Airvo 3 NIV Respiratory Support Device FDA UDI
Identifiers
- Catalog Number
- PT311US FDA UDI
- Primary DI / UDI-DI
- 09420012466679 FDA UDI
- 510(k) Number
- K233643 FDA UDI
- FDA Product Code
- MNT FDA UDI
- GMDN Term
- Professional BPAP/high-flow respiratory unit 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Professional BPAP/high-flow respiratory unit
Fisher & Paykel Healthcare by Fisher & Paykel Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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 |
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Manufacturer
- Manufacturer
- Fisher & Paykel Healthcare, Inc.
Sources (1)
- FDA UDI ae56fd95-1c8b-4eec-83a2-8c14520826c2 37 fields · synced May 30, 2026