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konsung
FDA UDIEUDAMEDClass II (US FDA UDI)
by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd.
Identity
- Trade Name
- konsung FDA UDI
- Generic Name
- Stationary oxygen concentrator FDA UDI
- Device Name
- The Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults. FDA UDI
- Model / Reference
- KSOC-5 FDA UDI
- Description
- The Oxygen Concentrator is intended to be used by patients with respiratory disorders who require supplemental oxygen. The device can be used in home, institution environments. The device is not intended to sustain or support life. The device is intended for use in adults. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06934822565031 FDA UDI
- 510(k) Number
- K223740 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
MR Unsafe FDA UDI
Category: Stationary oxygen concentrator
konsung by Jiangsu Konsung Bio Medical Science and Technology Co., Ltd. — Class II — MDD, IVDD, MDR, FDA UDI — listed in FDA GUDID, EUDAMED
Similar devices
Also classified as Stationary oxygen concentrator.
- MARK 5 NUVO LITE — Nidek Medical Products Inc. · Class II
- NewLife Elite — Airsep Corp. · Class II
- OxyHome — Mv Life LLC · Class II
- NewLife Intensity 10 — CAIRE INC. · 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
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
European Union Unknown
IVDD
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
Sources (2)
- FDA UDI 303adb54-061a-4284-bfdd-33566c8f17e6 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026