Identity
- Trade Name
- REMstar SE FDA UDI
- Generic Name
- Home CPAP unit FDA UDI
- Device Name
- REMstar SE CPAP System with SD Slot, INTL FDA UDI
- Model / Reference
- REMstar SE with SD Slot, INTL FDA UDI
- Description
- REMstar SE CPAP System with SD Slot, INTL FDA UDI
Identifiers
- Catalog Number
- 221P FDA UDI
- Primary DI / UDI-DI
- 00606959038370 FDA UDI
- 510(k) Number
- FDA Product Code
- BZD FDA 510(k)FDA UDI
- GMDN Term
- Home CPAP unit FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5905 FDA 510(k)
- Regulation Number
- 868.5905 FDA 510(k)FDA UDI
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
No
FDA UDI
Remstar Se by Respironics, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K130077 | Class II | Active |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (2)
- FDA 510(k) K130077 24 fields · synced Jun 18, 2026
- FDA UDI bab6145e-3689-4180-828b-6de63b136f51 37 fields · synced May 22, 2026