FDA UDI
In Commercial Distribution
🇺🇸 United States
Serim® GUARDIAN™ Blood Leak Test Strips
DI: M17451191
·
Model: Blood Leak 50's
·
SERIM RESEARCH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
50
Basic Information
- Brand Name
- Serim® GUARDIAN™ Blood Leak Test Strips
- Primary DI
- M17451191
- Version / Model
- Blood Leak 50's
- Catalog Number
- 5119
- Company Name
- SERIM RESEARCH CORPORATION
- Labeler DUNS
- 605151018
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2026-01-29
- Public Version
- 1
- Public Version Date
- 2026-02-06
- Public Version Status
- New
- Public Device Record Key
- 5d307d85-190c-4fbc-a278-f550857e3857
Device Description
Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is suspected during the hemodialysis procedure.
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 |
|---|---|---|---|---|
| FJD | Detector, Leak, Blood | Gastroenterology, Urology | 876.5820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32128 | Haemodialysis system blood leak detector | An electrically-powered integral unit of a haemodialysis system that detects blood leaks in the effluent side of the dialysate within the system and sounds an alarm if there is blood detected on this non-blood side. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | M17451190 | HIBCC | ||||
| Primary | M17451191 | HIBCC |
Customer Contacts
- Phone
- 800-542-4670
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K012115 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius