Identity
- Trade Name
- Sodium Bicarbonate Mixing and Distribution System FDA UDI
- Generic Name
- Haemodialysis system fluid mixer FDA UDI
- Device Name
- IsoMix PRO Sodium Bicarbonate Mixing and Distribution System (MD702480-SS) FDA UDI
- Model / Reference
- IsoMix PRO FDA UDI
- Description
- IsoMix PRO Sodium Bicarbonate Mixing and Distribution System (MD702480-SS) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00852456007085 FDA UDI
- 510(k) Number
- K112427 FDA UDI
- FDA Product Code
- FIN 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
Yes
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
Sodium Bicarbonate Mixing and Distribution 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
- Dry Bicarb Mixing System — Rockwell Medical · Class II
- 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
- Acidified Concentrate Distribution and Storage (ACDS) 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 464d5635-080f-431f-8285-555807df6977 34 fields · synced Jun 8, 2026