Identity
- Trade Name
- NXSTAGE SYSTEM ONE PLUS FDA UDI
- Generic Name
- Haemodialysis system, institutional/home-use FDA UDI
- Model / Reference
- NX1000-10-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- M535NX100010A0 FDA UDI
- FDA Product Code
- KDI FDA UDI
- GMDN Term
- Haemodialysis system, institutional/home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5860 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: Haemodialysis system, institutional/home-use
Nxstage System One Plus by NxStage Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system, institutional/home-use.
- 2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
- Moda-flx Hemodialysis System — Diality, Inc. · Class II
- 2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
- Moda-flx Hemodialysis System — Diality, Inc. · Class II
- 2008® Series Hemodialysis Machines — Fresenius Usa, Inc. · Class II
- Moda-flx Hemodialysis System — Diality, Inc. · Class II
- Tablo(R) Hemodialysis System — Outset Medical, Inc. · Class II
- DIMI RRT System — Dialco Medical Inc · Class II
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
- NxStage Medical, Inc.
Sources (1)
- FDA UDI d8f9e687-4af3-4321-8127-479ec729e126 34 fields · synced Jun 9, 2026