Identity
- Trade Name
- Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips FDA UDI
- Generic Name
- Multi-parameter device tester FDA UDI
- Device Name
- SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment. FDA UDI
- Model / Reference
- 5167 FDA UDI
- Description
- SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water used to prepare dialysate. The test also indicates the concentration of residual chlorine (chlorine bleach) remaining in the water used to rinse dialysate lines following disinfection of hemodialysis equipment. FDA UDI
Identifiers
- Catalog Number
- 5167 FDA UDI
- Primary DI / UDI-DI
- M17451671 FDA UDI
- 510(k) Number
- K080712 FDA UDI
- FDA Product Code
- MSY 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 ULTRA 0.1™ 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 23f45c46-bd24-4f5b-a625-6b35427eebeb 37 fields · synced May 31, 2026