Sonoclot® aiACT Kit 800-0442

GUDID B55880004420

The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The aiACT test is an activated whole blood clotting time test which uses a blend of celite and clay for contact activation. It may also be used with citrated whole blood. The aiACT Kit is only intended for high dose (ACT greater or equal to 400 seconds, on Sonoclot Analyzer) heparin anticoagulation management as typically encountered during cardiopulmonary bypass surgery. The aiACT test provides ACT results that are substantially unaffected by aprotinin. When used with the Sonoclot Analyzer System, the aiACT test provides quantitative Onset/ACT and Clot Rate results. Do not use the aiACT test for platelet function assessment. Each kit contains 100 lidded yellow plastic activation cuvettes, 100 probes, and instructions for use. The activation cuvettes contain a controlled amount of contact activator and a magnetic stir bar.

SIENCO, INC.

Multiple coagulation factor IVD, kit, clotting

• Primary Device ID: B55880004420
• NIH Device Record Key: f1e7196b-d610-4232-8b6d-cf7d3587c92b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sonoclot® aiACT Kit
• Version Model Number: 800-0442
• Catalog Number: 800-0442
• Company DUNS: 064039514
• Company Name: SIENCO, INC.
• 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: true
• 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: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com
• Phone: 303-420-1148
• Email: info@sienco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B55880004420 [Unit of Use]
HIBCC	B55880004421 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032952

FDA Product Code

• JBP: Activated Whole Blood Clotting Time

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: 2021-07-27
• Device Publish Date: 2021-07-19

On-Brand Devices [Sonoclot® aiACT Kit]

• B55880004420: The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet
• B55880004410: The aiACT Kit is an in vitro diagnostic test for use with the Sonoclot® Coagulation & Platelet