Serim® GUARDIAN™ Residual Chlorine Test Strips 5100A

GUDID M1745100A1

Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.

SERIM RESEARCH CORPORATION

Haemodialysis equipment residual chlorine test strip

• Primary Device ID: M1745100A1
• NIH Device Record Key: 2e53b621-681f-490b-b927-1654ccbd2523
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serim® GUARDIAN™ Residual Chlorine Test Strips
• Version Model Number: 5100A
• Catalog Number: 5100A
• Company DUNS: 605151018
• Company Name: SERIM RESEARCH CORPORATION
• Device Count: 100
• 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: true
• 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
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: customerservice@serim.com
• Phone: 800-542-4670
• Email: 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	M1745100A0 [Unit of Use]
HIBCC	M1745100A1 [Primary]
HIBCC	M1745100A2 [Package]; Package: Kit [6 Units]; In Commercial Distribution

FDA Product Code

• FKJ: Filter, Blood, Dialysis

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2026-02-09
• Device Publish Date: 2016-08-29

On-Brand Devices [Serim® GUARDIAN™ Residual Chlorine Test Strips]

• M1745100C2: Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleac
• M1745100A1: Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach