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Acidified Concentrate Distribution and Storage (ACDS) System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Acidified Concentrate Distribution and Storage (ACDS) System FDA UDI
- Generic Name
- Haemodialysis system fluid mixer FDA UDI
- Device Name
- Acidified Concentrate Distribution and Storage System (ACDS System) FDA UDI
- Model / Reference
- MD704262 FDA UDI
- Description
- Acidified Concentrate Distribution and Storage System (ACDS System) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852456007092 FDA UDI
- 510(k) Number
- K120005 FDA UDI
- FDA Product Code
- KPO FDA UDI
- GMDN Term
- Haemodialysis system fluid mixer 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
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
Yes
FDA UDI
Category: Haemodialysis system fluid mixer
Acidified Concentrate Distribution and Storage (ACDS) System by Isopure, Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haemodialysis system fluid mixer.
- Dry Acid Dissolution Unit — Fresenius Usa, Inc. · Class II
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- Dry Acid Mixing System — Rockwell Medical · Class II
- Dry Acid Dissolution Unit — Fresenius Usa, Inc. · Class II
- Dry Acid Mixing System — Rockwell Medical · Class II
- Sodium Bicarbonate Mixing and Distribution System — Isopure, Corp. · 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
- Isopure, Corp.
Sources (1)
- FDA UDI f359f2ba-1fa4-4dcd-8200-3bd9236ba029 34 fields · synced Jun 6, 2026