FDA UDI
In Commercial Distribution
🇺🇸 United States
Serim® GUARDIAN™ HiSENSE™ Test Kit
DI: M17451091
·
Model: 5109
·
SERIM RESEARCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
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Basic Information
- Brand Name
- Serim® GUARDIAN™ HiSENSE™ Test Kit
- Primary DI
- M17451091
- Version / Model
- 5109
- Catalog Number
- 5109
- Company Name
- SERIM RESEARCH CORPORATION
- Labeler DUNS
- 605151018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2026-02-09
- Public Version Status
- Update
- Public Device Record Key
- 478bd335-3a6a-471b-aaec-dba9f403ed61
Device Description
The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FIP | Subsystem, Water Purification | Gastroenterology, Urology | 876.5665 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62445 | Haemodialysis dialysate water chlorine test kit | A collection of reagents and other associated materials intended to be used to rapidly indicate, through colour change, the concentration of total chlorine in water used to prepare dialysate solution for haemodialysis. It includes test tubes, a colorimetric reagent (e.g., DPD, potassium iodide) which produces a colour change upon reaction with chlorine/chloramine, and a visual standard for colour comparison. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M17451092 | HIBCC | Kit | 5 | In Commercial Distribution | |
| Primary | M17451091 | HIBCC | ||||
| Unit of Use | M17451090 | HIBCC |
Customer Contacts
- Phone
- 800-542-4670
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K952215 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius