Identity
- Trade Name
- AF531 FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- AF531 Mask with Entrainment Elbow, Leak 2, 4 Point Headgear, Single Use, China, Small FDA UDI
- Model / Reference
- AF531 Mask EE, LEAK 2, with 4 PT Headgear, SU, Small, CN FDA UDI
- Description
- AF531 Mask with Entrainment Elbow, Leak 2, 4 Point Headgear, Single Use, China, Small FDA UDI
Identifiers
- Catalog Number
- 1119098 FDA UDI
- Primary DI / UDI-DI
- 00606959008793 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP face mask, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The AF531 Mask with Entrainment Elbow, Leak 2, 4 Point Headgear, Single Use device provides a reliable and efficient way to deliver continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) to patients with respiratory needs. Made of flexible materials, it features a durable design that can be easily cleaned and disinfected. This single-use mask is available in various sizes and designs, making it suitable for use by healthcare professionals and individuals with respiratory conditions.
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Respironics, Inc.
Sources (1)
- FDA UDI fd4eec7a-5f06-475a-ab56-b8858d5b07e7 37 fields · synced Jun 21, 2026