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AmeriWater Water Purification System for Hemodialysis
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- AmeriWater Water Purification System for Hemodialysis FDA UDI
- Generic Name
- Reverse-osmosis water purification system FDA UDI
- Device Name
- AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis. FDA UDI
- Model / Reference
- Complete System FDA UDI
- Description
- AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817927020338 FDA UDI
- 510(k) Number
- K991519 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Reverse-osmosis 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
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
No
FDA UDI
Category: Reverse-osmosis water purification system
AmeriWater Water Purification System for Hemodialysis by Ameriwater Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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
- Ameriwater Llc.
Sources (1)
- FDA UDI 0f397fdc-4ac8-41ca-b433-5c4496bb481d 34 fields · synced May 30, 2026