Identity
- Trade Name
- DreamStation Go FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- DreamStation Go Auto, with Bluetooth, Flagship, Nordics FDA UDI
- Model / Reference
- DreamStation Go Auto, with Bluetooth, Flagship, Nordics FDA UDI
- Description
- DreamStation Go Auto, with Bluetooth, Flagship, Nordics FDA UDI
Identifiers
- Catalog Number
- NDG502S15 FDA UDI
- Primary DI / UDI-DI
- 00606959048447 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Home CPAP unit
DreamStation Go by Respironics, Inc. — 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, Inc.
Sources (1)
- FDA UDI d8e14702-307a-4459-97fe-1de3a914a6cd 36 fields · synced May 31, 2026