Serim® GUARDIAN™ Blood Leak Test Strips

Basic Information

• Brand Name: Serim® GUARDIAN™ Blood Leak Test Strips
• Primary DI: M1745119C1
• Version / Model: 5119C
• Catalog Number: 5119C
• Company Name: SERIM RESEARCH CORPORATION
• Labeler DUNS: 605151018
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2017-02-12
• Public Version: 4
• Public Version Date: 2026-02-09
• Public Version Status: Update
• Public Device Record Key: e7eed404-9689-42d2-8b91-682f75550c0d
• Distribution End Date: 2024-12-31

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: No
• 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
Package	M1745119C2	HIBCC	Kit	2	Not in Commercial Distribution	2024-12-31
Primary	M1745119C1	HIBCC
Unit of Use	M1745119C0	HIBCC
Package	M1745119IN	HIBCC	Kit	1	Not in Commercial Distribution	2024-12-31

Customer Contacts

• Phone: [phone]
• Email: [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