Identity
- Trade Name
- SDS Bicarb Systems FDA UDI
- Generic Name
- Haemodialysis bicarbonate solution preparation mixer FDA UDI
- Model / Reference
- SDS,REMOTE,3 ACID,1 BICARB,HD,70G TANK FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817492021167 FDA UDI
- FDA Product Code
- FIN FDA UDI
- GMDN Term
- Haemodialysis bicarbonate solution preparation 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
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
Dimensions & Sizes
- Size
- Height — 58 Inch FDA UDIDepth — 55 Inch FDA UDIWidth — 92 Inch FDA UDI
Category: Haemodialysis bicarbonate solution preparation mixer
SDS Bicarb Systems by Mar Cor Purification, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Mar Cor Purification, Inc.
Sources (1)
- FDA UDI 95a12168-5bba-4e8a-960e-f46497f369e5 35 fields · synced May 30, 2026