Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips

Basic Information

• Brand Name: Serim® GUARDIAN™ Quick Dip Residual Chlorine Test Strips
• Primary DI: M17452120
• Version / Model: 5212
• Catalog Number: 5212
• Company Name: SERIM RESEARCH CORPORATION
• Labeler DUNS: 605151018
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2026-03-30
• Public Version: 1
• Public Version Date: 2026-04-07
• Public Version Status: New
• Public Device Record Key: 64bb5305-f655-40a0-94e7-f80f809c8a32

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
FKJ	Filter, Blood, Dialysis	Gastroenterology, Urology	876.5820	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62444	Haemodialysis equipment residual chlorine test strip	A sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change and visual comparison to a colour chart, the concentration of residual chlorine in water samples. It is typically used as a means to test whether chlorine has been adequately rinsed from haemodialysis equipment following disinfection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	M17452121	HIBCC	Kit	6	In Commercial Distribution
Unit of Use	M17452122	HIBCC
Primary	M17452120	HIBCC

Customer Contacts

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

Storage Conditions

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