Serim® GUARDIAN™ Residual Formaldehyde Test Strips

Basic Information

• Brand Name: Serim® GUARDIAN™ Residual Formaldehyde Test Strips
• Primary DI: M17451121
• Version / Model: 5112
• Catalog Number: 5112
• Company Name: SERIM RESEARCH CORPORATION
• Labeler DUNS: 605151018
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2016-09-08
• Public Version: 4
• Public Version Date: 2026-02-06
• Public Version Status: Update
• Public Device Record Key: 0498db39-1802-49e3-a0c9-7db0e58b5f61
• Distribution End Date: 2025-07-31

Device Description

Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.

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
LIF	Dialyzer Reprocessing System	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35001	Multi-parameter device tester	A battery-powered electronic device designed to measure two or more parameters (e.g., temperature, conductivity, pressure, pH, flow) to calibrate or test a medical device (e.g., haemodialysis equipment, anaesthesia machine, suction system, ophthalmic laser). It typically consists of a hand-held electronic box with appropriate connections and a digital display; dedicated measuring devices (e.g., probe, sensor, electrode, buffer solution) are typically included. It is not dedicated to a specific clinical discipline and is intended to be used by a professional in a professional setting (e.g., clinical engineering).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M17451121	HIBCC
Unit of Use	M17451120	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K914123	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 7 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius