Identity
- Trade Name
- ARYA FDA UDI
- Generic Name
- Mobile/portable oxygen concentrator FDA UDI
- Device Name
- The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation unit which is based on molecular sieves selective adsorption of nitrogen from air. It can continuously generate oxygen with the purity 93%±3% at ambient temperature. The adsorbed nitrogen can be desorbed by decreasing the adsorbed bed pressure resulting cyclical adsorption-desorption operation. The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it’s not intended to support or sustain life. FDA UDI
- Model / Reference
- ARYA5L FDA UDI
- Description
- The Oxygen Concentrator is a PSA oxygen generator. The PSA (pressure swing adsorption) oxygen generator is an air separation unit which is based on molecular sieves selective adsorption of nitrogen from air. It can continuously generate oxygen with the purity 93%±3% at ambient temperature. The adsorbed nitrogen can be desorbed by decreasing the adsorbed bed pressure resulting cyclical adsorption-desorption operation. The Oxygen Concentrator provides supplemental low flow oxygen therapy for adult in the home, nursing homes, patient care facilities, etc. It is available by prescription only under the supervision of a physician, and it’s not intended to support or sustain life. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971072050528 FDA UDI
- 510(k) Number
- K102245 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
No
FDA UDI
MR Unsafe FDA UDI
Category: Mobile/portable oxygen concentrator
Arya by Sprylyfe Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Mobile/portable oxygen concentrator.
- Invacare F-Tube, PVC for PerectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- SimplyGo Mini — Respironics, Inc. · Class II
- SimplyGo Mini — Respironics, Inc. · Class II
- SimplyGo Mini — Respironics, Inc. · Class II
- FreeStyle — CAIRE INC. · Class II
- Invacare Panel Control for PerfectO2 and PerfectO2V — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- DISCOV-R — BELLUSCURA PLC · Class II
- GCE — GAS CONTROL EQUIPMENT LIMITED · Class II
Cleared under the same submission
K102245 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sprylyfe Inc
Sources (1)
- FDA UDI ecdf1ec3-64cb-4518-808a-c93b5be56b48 34 fields · synced May 30, 2026