Identity
- Trade Name
- PUREFLOW SL FDA UDI
- Generic Name
- Haemodialysis system dialysate delivery unit FDA UDI
- Model / Reference
- NX2000-2-A FDA UDI
Identifiers
- Primary DI / UDI-DI
- M535NX20002A0 FDA UDI
- FDA Product Code
- FKR FDA UDI
- GMDN Term
- Haemodialysis system dialysate delivery unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haemodialysis system dialysate delivery unit
Pureflow Sl by NxStage Medical, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system dialysate delivery unit.
- Hemodialysis Delivery System — NIKKISO CO., LTD. · Class II
- HEMODIALYSIS DELIVERY SYSTEM — NIKKISO CO., LTD. · Class II
- HEMODIALYSIS DELIVERY SYSTEM — NIKKISO CO., LTD. · Class II
- PUREFLOW SL — NxStage Medical, Inc. · Class II
- PUREFLOW SL — NxStage Medical, Inc. · Class II
- PUREFLOW SL — NxStage Medical, Inc. · Class II
- PUREFLOW SL - CONTROL UNIT — NxStage Medical, Inc. · Class II
- PUREFLOW SL KIT — NxStage Medical, Inc. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- NxStage Medical, Inc.
Sources (2)
- FDA UDI 1d67a649-ba79-484b-9559-be3f4d253b80 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026