Identity
- Trade Name
- DRIVEMEDICAL FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- SleepMask Accessories Product Description: Replacement NP Cushion, SM, 1/ea FDA UDI
- Model / Reference
- 100NPS-CUSHION FDA UDI
- Description
- SleepMask Accessories Product Description: Replacement NP Cushion, SM, 1/ea FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822383543864 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable 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
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
Drivemedical by Drive Devilbiss Healthcare — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drive Devilbiss Healthcare
Sources (1)
- FDA UDI cb21f50e-e799-4041-8bc8-a92d78956520 34 fields · synced Jun 8, 2026