Identity
- Trade Name
- Water Purification System for Hemodialysis FDA UDI
- Generic Name
- Combination water purification system FDA UDI
- Device Name
- Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water. FDA UDI
- Model / Reference
- Complete System FDA UDI
- Description
- Nelson Water System's Water Purification System for Hemodialysis is intended to be used for purifying the water used in hemodialysis treatment. It removes organic, inorganic, and microbial contaminants from the water. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860006352127 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Combination water purification system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 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
No
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
Category: Combination water purification system
Water Purification System for Hemodialysis by Nelson Environmental Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Combination water purification system.
- Brine Tank — SPECIALITY WATER TECHNOLOGY · Class II
- MEDIPAC, 2880GPD, DIRECT FEED, 115V — Better Water, Inc. · Class II
- Softener Tank — SPECIALITY WATER TECHNOLOGY · Class II
- Softener Tank — SPECIALITY WATER TECHNOLOGY · Class II
- MATRIX-PRETREAT, 1.5", 230V, CPVC — Better Water, Inc. · Class II
- De-Alkalizer — SPECIALITY WATER TECHNOLOGY · Class II
- HistoSonics — HISTOSONICS, INC · Class I
- HistoSonics — HISTOSONICS, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nelson Environmental Technologies, Inc.
Sources (1)
- FDA UDI 8a21db4a-5c67-42a0-87e7-8da6994ea1b1 33 fields · synced Jun 20, 2026