Identity
- Trade Name
- Arya FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery FDA UDI
- Model / Reference
- AS200-6 FDA UDI
- Description
- Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery FDA UDI
Identifiers
- Primary DI / UDI-DI
- M766AS20060 FDA UDI
- 510(k) Number
- K020324 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Mobile/portable oxygen concentrator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5440 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: Mobile/portable oxygen concentrator
Arya by Caire Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K020324 also covers:
- AirSep FreeStyle 5 — CAIRE INC.
- Arya — CAIRE INC.
- Arya — CAIRE INC.
- Arya — CAIRE INC.
- Arya — CAIRE INC.
- FREESTYLE — CAIRE INC.
- FreeStyle Comfort — CAIRE INC.
- FreeStyle Comfort — CAIRE INC.
- FreeStyle Comfort — CAIRE INC.
- FreeStyle Comfort — CAIRE INC.
- FreeStyle Comfort — CAIRE INC.
- FreeStyle Comfort — CAIRE 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
- Caire Inc.
Sources (1)
- FDA UDI b9acb059-9566-4b6c-aeb3-1a1c2f7337a7 34 fields · synced May 30, 2026