Serim® GUARDIAN™ Peracetic Acid Test Strips 5106

GUDID M17451061

SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.

SERIM RESEARCH CORPORATION

Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip Medical device disinfection solution test strip

• Primary Device ID: M17451061
• NIH Device Record Key: 3dcb736e-b1a5-4059-9200-26fc94ce2725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Serim® GUARDIAN™ Peracetic Acid Test Strips
• Version Model Number: 5106
• Catalog Number: 5106
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M17451060 [Unit of Use]
HIBCC	M17451061 [Primary]
HIBCC	M17451062 [Package]; Package: Kit [6 Units]; In Commercial Distribution

FDA Product Code

• JOJ: Indicator, Physical/Chemical Sterilization Process

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: 2024-04-16
• Device Publish Date: 2016-09-08

Devices Manufactured by SERIM RESEARCH CORPORATION

• M17451061 - Serim® GUARDIAN™ Peracetic Acid Test Strips: 2024-04-16SERIM® GUARDIAN™ Peracetic Acid Test Strips indicate the concentration (potency) of peracetic acid in dialyzer reprocessing concentrates such as Renalin® Cold Sterilant, PerAldecide™, Puristeril® 340, Peracidin™ and Micro-X®.
• 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.