Identity
- Trade Name
- ReddyPort FDA UDI
- Generic Name
- CPAP/BPAP face mask, single-use FDA UDI
- Device Name
- Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1 FDA UDI
- Model / Reference
- RP-531-L1 FDA UDI
- Description
- Multi-functional NIV elbow for Philips Respironics 531 and Performax Masks, Leak 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850001175005 FDA UDI
- 510(k) Number
- K171827 FDA UDI
- FDA Product Code
- MNS 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: CPAP/BPAP face mask, single-use
ReddyPort by Smd Manufacturing Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 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 |
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Manufacturer
- Manufacturer
- Smd Manufacturing Llc
Sources (1)
- FDA UDI 327384b2-aac6-4fb4-8ede-31d6b162e013 35 fields · synced Jun 1, 2026