Serim® GUARDIAN™ HiSENSE™ Test Kit 5109

GUDID M17451092

The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.

SERIM RESEARCH CORPORATION

Haemodialysis dialysate water chlorine test kit

• Primary Device ID: M17451092
• NIH Device Record Key: 478bd335-3a6a-471b-aaec-dba9f403ed61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serim® GUARDIAN™ HiSENSE™ Test Kit
• Version Model Number: 5109
• Catalog Number: 5109
• Company DUNS: 605151018
• Company Name: SERIM RESEARCH CORPORATION
• Device Count: 20
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M17451090 [Unit of Use]
HIBCC	M17451091 [Primary]
HIBCC	M17451092 [Package]; Contains: M17451091; Package: Kit [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952215

FDA Product Code

• FIP: Subsystem, Water Purification

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: 2026-02-09
• Device Publish Date: 2016-09-19

Devices Manufactured by SERIM RESEARCH CORPORATION

• M1745100A1 - Serim® GUARDIAN™ Residual Chlorine Test Strips: 2026-02-09 Serim® GUARDIAN™ RESIDUAL CHLORINE Test Strips indicate the concentration of chlorine bleach (sodium hypochlorite) remaining
• M17451052 - Serim® GUARDIAN™ Residual Peroxide Test Strips: 2026-02-09 Serim® GUARDIAN™ Residual Peroxide Test Strips measure the concentration of peroxide remaining in dialysate lines and dialyze
• M17451092 - Serim® GUARDIAN™ HiSENSE™ Test Kit: 2026-02-09The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water used to prepare dialysate.
• M17451092 - Serim® GUARDIAN™ HiSENSE™ Test Kit: 2026-02-09 The Serim® GUARDIAN™ HiSENSE™ Test Kit indicates low levels of total chlorine (chloramine and/or free chlorine) in water us
• M1745119C2 - Serim® GUARDIAN™ Blood Leak Test Strips: 2026-02-09 Serim® GUARDIAN™ Blood Leak Test Strips provide a rapid method to test dialysate for blood if a dialyzer membrane leak is sus
• M17451212 - Serim® DISINTEK™ OPA Test Strips: 2026-02-09 Serim® DISINTEK™ OPA Test Strips are chemical indicators for use in determining whether the concentration of ortho-phthalalde
• M1745136A1 - Serim® DISINTEK™ GTA 1.5% Test Strips: 2026-02-09 Serim DISINTEK GTA 1.5% Test Strips are used to determine whether the glutaraldehyde concentration is above or at/below the Mini
• 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