Identity
- Trade Name
- MARK 5 NUVO LITE FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- 115V OCSI OXYGEN CONCENTRATOR -- FOR EXPORT, SPANISH MANUAL FDA UDI
- Model / Reference
- 525EX FDA UDI
- Description
- 115V OCSI OXYGEN CONCENTRATOR -- FOR EXPORT, SPANISH MANUAL FDA UDI
Identifiers
- Catalog Number
- 525EX FDA UDI
- Primary DI / UDI-DI
- 00038214001131 FDA UDI
- 510(k) Number
- K123738 FDA UDI
- FDA Product Code
- CAW FDA UDI
- GMDN Term
- Stationary 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Stationary oxygen concentrator
Mark 5 Nuvo Lite by Nidek Medical Products Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Stationary oxygen concentrator.
- NewLife Elite — Airsep Corp. · Class II
- OxyHome — Mv Life LLC · Class II
- NewLife Intensity 10 — CAIRE INC. · Class II
- konsung — Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. · Class II
- NewLife Intensity — Airsep Corp. · Class II
- DeVilbiss — DeVilbiss Healthcare LLC. · Class II
- Oxygen Concentrator — Proactive Medical Products · Class II
- Inogen At Home Stationary Concentrator — Inogen, Inc. · Class II
Cleared under the same submission
K123738 also covers:
- MARK 5 NUVO 10 — Nidek Medical Products Inc.
- MARK 5 NUVO 10 — Nidek Medical Products Inc.
- MARK 5 NUVO 10 — Nidek Medical Products Inc.
- MARK 5 NUVO 8 — Nidek Medical Products Inc.
- MARK 5 NUVO 8 — Nidek Medical Products Inc.
- MARK 5 NUVO 8 — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products Inc.
- MARK 5 NUVO LITE — Nidek Medical Products 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
- Nidek Medical Products Inc.
Sources (1)
- FDA UDI 8157a51f-0700-43d6-aa3a-48fd76f96fc7 37 fields · synced May 30, 2026