QwikCheck® CS-202790

GUDID B205CS2027901

The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.

CS MEDICAL, LLC

Peracetic acid device disinfectant/sterilant test strip

• Primary Device ID: B205CS2027901
• NIH Device Record Key: 3e3ebe65-bfba-4a4b-be1a-790bb6986adc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QwikCheck®
• Version Model Number: 202790
• Catalog Number: CS-202790
• Company DUNS: 603864294
• Company Name: CS MEDICAL, LLC
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B205CS2027901 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230381

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-08
• Device Publish Date: 2023-07-31

Devices Manufactured by CS MEDICAL, LLC

• B205CS2027901 - QwikCheck®: 2023-08-08The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingredient in AquaCide, is above or below the Minimum Recommended Concentration (MRC) of 1750 ppm.
• B205CS2027901 - QwikCheck®: 2023-08-08 The QwikCheck Chemical Indicator is for use in Ethos to determine whether the concentration of peracetic acid, the active ingred
• B205CSAQ31 - AquaCide®: 2023-08-08 PAA Cleaner High-Level Disinfectant
• B205CSECD1001 - Ethos®: 2023-08-08 The Ethos automated ultrasound probe cleaner disinfector is designed to provide cleaning and high-level disinfection of surface
• B205CSTD121 - TD-12®: 2020-04-23 PAA High-Level Disinfectant
• B205CSTD2001 - TD 200®: 2020-04-23 TD 200® Automated TEE Probe Disinfector
• B205CSTCD1000 - TEEClean®: 2019-10-03 The TEEClean automated cleaner disinfector is designed to provide enzymatic cleaning and high-level disinfection of Transesophag
• B205TD100A0 - TD 100®: 2019-04-09 TD 100® Automated TEE Probe Disinfector
• B205TD100B0 - TD 100®: 2019-04-09 TD 100® Automated TEE Probe Disinfector