Identity
- Trade Name
- DreamStation FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- DreamStation BiPAP S/T30 AAM, no Bluetooth, INTL FDA UDI
- Model / Reference
- DreamStation BiPAP S/T30 AAM no Bluetooth, INTL FDA UDI
- Description
- DreamStation BiPAP S/T30 AAM, no Bluetooth, INTL FDA UDI
Identifiers
- Catalog Number
- INX1030S19 FDA UDI
- Primary DI / UDI-DI
- 00606959425026 FDA UDI
- 510(k) Number
- K102465 FDA UDI
- FDA Product Code
- MNS FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5895 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
No
FDA UDI
Category: Portable electric ventilator
DreamStation by Respironics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Portable electric ventilator.
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Cleared under the same submission
K102465 also covers:
- BIPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP AVAPS — Respironics, Inc.
- BiPAP S/T C-Series — Respironics, Inc.
- BiPAP S/T C-Series — Respironics, Inc.
- BiPAP S/T C-Series — Respironics, Inc.
- BiPAP S/T C-Series — Respironics, Inc.
- BiPAP ST — Respironics, Inc.
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 925cc6ad-c098-441c-b68d-ae052f6a3d74 37 fields · synced May 30, 2026