Serim® GUARDIAN™ Residual Chlorine Test Strips 5100C

GUDID M1745100C2

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

SERIM RESEARCH CORPORATION

Multi-parameter device tester

• Primary Device ID: M1745100C2
• NIH Device Record Key: 7ce6a324-9178-4fea-943c-f64d50c138ff
• Commercial Distribution Discontinuation: 2025-01-08
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Serim® GUARDIAN™ Residual Chlorine Test Strips
• Version Model Number: 5100C
• Catalog Number: 5100C
• 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: 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
• 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
• 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	M1745100C0 [Unit of Use]
HIBCC	M1745100C1 [Primary]
HIBCC	M1745100C2 [Package]; Contains: M1745100C1; Package: kit [12 Units]; Discontinued: 2024-12-31; Not 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: 2026-01-30
• Device Publish Date: 2016-08-29

Devices Manufactured by SERIM RESEARCH CORPORATION

• M1745100C2 - Serim® GUARDIAN™ Residual Chlorine Test Strips: 2026-01-30Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remaining in the solution used to rinse dialysate lines following disinfection of hemodialysis equipment.
• M1745100C2 - Serim® GUARDIAN™ Residual Chlorine Test Strips: 2026-01-30 Serim® GUARDIAN™ Residual Chlorine Test Strips indicating the concentration of chlorine bleach (sodium hypochlorite) remainin
• M1745116A1 - Serim® GUARDIAN™ Bicarb pH II Test Strips: 2026-01-30 Serim® GUARDIAN™ Bicarb pH II Test Strips are designed to test bicarbonate concentrate and/or final dialysate solutions for t
• M1745140S2 - Serim® PyloriTek® Test Kit: 2026-01-30 The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobac
• M1745167IN2 - Serim® GUARDIAN™ HiSENSE ULTRA 0.1™ Test Strips: 2026-01-30 SERIM GUARDIAN HiSENSE ULTRA 0.1 Test Strips indicates low levels of total chlorine (chloramines/free chlorine) in feed water us
• M17451061 - Serim® GUARDIAN™ Peracetic Acid Test Strips: 2024-04-16 SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing
• M17451221 - Serim® PeriScreen™ Test Strips: 2022-11-28 Serim PeriScreen Test Strips indicate the presence of leukocytes (white blood cells) in peritoneal dialysate effluent.