Identity
- Trade Name
- Serim® GUARDIAN™ Bicarb pH II Test Strips FDA UDI
- Generic Name
- Multi-parameter device tester FDA UDI
- Device Name
- Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems. FDA UDI
- Model / Reference
- 5116A FDA UDI
- Description
- Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for the appropriate pH where bicarbonate and acid and water are mixed in closed systems. FDA UDI
Identifiers
- Catalog Number
- 5116A FDA UDI
- Primary DI / UDI-DI
- M1745116A1 FDA UDI
- 510(k) Number
- K945491 FDA UDI
- FDA Product Code
- MNV FDA UDI
- GMDN Term
- Multi-parameter device tester 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-parameter device tester
Serim® GUARDIAN™ Bicarb pH II Test Strips by Serim Research Corp. — 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
- Serim Research Corp.
Sources (1)
- FDA UDI f281f04b-6472-4e0e-8e69-c3856cea7091 37 fields · synced Jun 8, 2026