Identity
- Trade Name
- WhisperPak, Face Mask, Case 10 FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Model / Reference
- 00 FDA UDI
Identifiers
- Catalog Number
- 8-100337-00 FDA UDI
- Primary DI / UDI-DI
- 00884838075580 FDA UDI
- FDA Product Code
- BYE FDA UDI
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5965 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
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home CPAP unit
WhisperPak, Face Mask, Case 10 by Respironics Novametrix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 Novametrix, LLC
Sources (1)
- FDA UDI b5e39959-b86f-49e0-ab20-1e3c130eaf7a 35 fields · synced Jun 8, 2026