Identity
- Trade Name
- Renasol Liquid Bicarbonate Concentrate FDA UDI
- Generic Name
- Haemodialysis concentrate FDA UDI
- Device Name
- Renasol Liquid Bicarbonate Concentrate FDA UDI
- Model / Reference
- BC-1-L FDA UDI
- Description
- Renasol Liquid Bicarbonate Concentrate FDA UDI
Identifiers
- Catalog Number
- 67753012 FDA UDI
- Primary DI / UDI-DI
- 00677964000393 FDA UDI
- FDA Product Code
- FKQ FDA UDI
- GMDN Term
- Haemodialysis concentrate FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Renasol Liquid Bicarbonate Concentrate by Medivators Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Medivators Inc.
Sources (1)
- FDA UDI d91454e8-6d74-4aa2-8cf7-dc488a35ae0c 36 fields · synced Jun 8, 2026