Serim® GUARDIAN™ Residual Formaldehyde Test Strips 5112

GUDID M17451121

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

SERIM RESEARCH CORPORATION

Multi-parameter device tester

• Primary Device ID: M17451121
• NIH Device Record Key: 0498db39-1802-49e3-a0c9-7db0e58b5f61
• Commercial Distribution Discontinuation: 2025-07-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Serim® GUARDIAN™ Residual Formaldehyde Test Strips
• Version Model Number: 5112
• Catalog Number: 5112
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 7 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M17451120 [Unit of Use]
HIBCC	M17451121 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K914123

FDA Product Code

• LIF: Dialyzer Reprocessing System

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2026-02-06
• Device Publish Date: 2016-09-08

Devices Manufactured by SERIM RESEARCH CORPORATION

• M17451121 - Serim® GUARDIAN™ Residual Formaldehyde Test Strips: 2026-02-06 Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyzers or dialysate lines prior to use in hemodialysis.
• M17451121 - Serim® GUARDIAN™ Residual Formaldehyde Test Strips: 2026-02-06 Serim® GUARDIAN™ Residual Formaldehyde Test Strips measure the concentration of formaldehyde remaining after rinsing dialyze
• M17451190 - Serim® GUARDIAN™ Blood Leak Test Strips: 2026-02-06 Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is sus
• M1745140K2 - Serim® PyloriTek® Test Kit: 2026-02-06 The Serim PyloriTek Test Kit detects urease activity in gastric biopsy specimens for the presumptive identification of Helicobac
• 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