Identity
- Trade Name
- Serim® GUARDIAN™ HiSENSE™ Test Kit FDA UDI
- Generic Name
- Multi-parameter device tester FDA UDI
- Device Name
- The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate. FDA UDI
- Model / Reference
- 5109 FDA UDI
- Description
- The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate. FDA UDI
Identifiers
- Catalog Number
- 5109 FDA UDI
- Primary DI / UDI-DI
- M17451091 FDA UDI
- 510(k) Number
- K952215 FDA UDI
- FDA Product Code
- FIP FDA UDI
- GMDN Term
- Multi-parameter device tester FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5665 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™ HiSENSE™ Test Kit 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 478bd335-3a6a-471b-aaec-dba9f403ed61 37 fields · synced May 30, 2026