Serim® GUARDIAN™ Blood Leak Test Strips 5119C
GUDID M1745119C2
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.
SERIM RESEARCH CORPORATION
Haemodialysis system blood leak detector| Primary Device ID | M1745119C2 |
| NIH Device Record Key | e7eed404-9689-42d2-8b91-682f75550c0d |
| Commercial Distribution Discontinuation | 2024-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Serim® GUARDIAN™ Blood Leak Test Strips |
| Version Model Number | 5119C |
| Catalog Number | 5119C |
| Company DUNS | 605151018 |
| Company Name | SERIM RESEARCH CORPORATION |
| Device Count | 25 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com | |
| Phone | 800-542-4670 |
| customerservice@serim.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Handling Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M1745119C0 [Unit of Use] |
| HIBCC | M1745119C1 [Primary] |
| HIBCC | M1745119C2 [Package] Contains: M1745119C1 Package: Kit [2 Units] Discontinued: 2024-12-31 Not in Commercial Distribution |
| HIBCC | M1745119IN [Package] Contains: M1745119C1 Package: Kit [1 Units] Discontinued: 2024-12-31 Not in Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K012115
FDA Product Code
| FJD | Detector, Leak, Blood |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2026-02-09 |
| Device Publish Date | 2017-02-12 |
On-Brand Devices [Serim® GUARDIAN™ Blood Leak Test Strips]
| M17451190 | Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if |
| M1745119C2 | Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if |
Trademark Results [Serim]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SERIM 78274783 2879450 Live/Registered |
Serim Research Corporation 2003-07-16 |
 SERIM 78274290 2910647 Live/Registered |
Serim Research Corporation 2003-07-15 |
 SERIM 74187553 not registered Dead/Abandoned |
Serim Research Corporation 1991-07-22 |
 SERIM 74187552 not registered Dead/Abandoned |
Serim Research Corporation 1991-07-22 |
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