Identity
- Trade Name
- Restored Rest FDA UDI
- Generic Name
- Medical cushion cover FDA UDI
- Device Name
- CPAP mask cushion cover made of absorbent material. Helps make using a CPAP easier and more comfortable. Decreases slippage, leaks, and noise. Feels good on the skin. Keeps the cushion clean and extends the life of the cushion. Slips on the cushion easily and is held on by thin elastic. Patented design is slim and lightweight. As the cover goes on the cushion a space for the nose, or nose and mouth, opens automatically. Washable and reusable. FDA UDI
- Model / Reference
- Full Style L/XL FDA UDI
- Description
- CPAP mask cushion cover made of absorbent material. Helps make using a CPAP easier and more comfortable. Decreases slippage, leaks, and noise. Feels good on the skin. Keeps the cushion clean and extends the life of the cushion. Slips on the cushion easily and is held on by thin elastic. Patented design is slim and lightweight. As the cover goes on the cushion a space for the nose, or nose and mouth, opens automatically. Washable and reusable. FDA UDI
Identifiers
- Catalog Number
- 11 FDA UDI
- Primary DI / UDI-DI
- 00860009595811 FDA UDI
- FDA Product Code
- FRL FDA UDI
- GMDN Term
- Medical cushion cover FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5300 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Medical cushion cover
Restored Rest by Restored Rest LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical cushion cover.
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · Class I
- Jenx — JENX LIMITED · Class I
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · Class I
- Jenx — JENX LIMITED · Class I
- Action® — Action Products, Inc. · Class I
- Jenx — JENX LIMITED · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Restored Rest LLC
Sources (1)
- FDA UDI be807cee-8b0a-4a3f-83b4-a3d2eee40509 35 fields · synced May 30, 2026