Identity
- Trade Name
- PerforMax FDA UDI
- Generic Name
- CPAP/BPAP face mask, reusable FDA UDI
- Device Name
- PerforMax Mask with Standard Elbow, and 4 Point Headgear, Multi Patient Use, International, Extra Large FDA UDI
- Model / Reference
- PerforMax Mask w/SE, Plus 4 PT HDGR, MPU, INTL, XL FDA UDI
- Description
- PerforMax Mask with Standard Elbow, and 4 Point Headgear, Multi Patient Use, International, Extra Large FDA UDI
Identifiers
- Catalog Number
- 1080422 FDA UDI
- Primary DI / UDI-DI
- 00606959011977 FDA UDI
- 510(k) Number
- K092648 FDA UDI
- FDA Product Code
- CBK FDA UDI
- GMDN Term
- CPAP/BPAP face mask, reusable 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: CPAP/BPAP face mask, reusable
PerforMax by Respironics, Inc. — Class II — 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
- HOSPITAL FFM — RESMED PTY LTD · Class II
- AIRFIT F20 — Resmed Corp · Class II
- QUATTRO FX — RESMED PTY LTD · Class II
- Full Face CPAP Mask — Large — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class II
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Cleared under the same submission
K092648 also covers:
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
- PerforMax — Respironics, Inc.
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
- Respironics, Inc.
Sources (1)
- FDA UDI 11ec7ee2-5760-4e56-9acb-45b429504a1d 37 fields · synced May 30, 2026