1/4' X 3/32' X 48' TUBE PACE SDC04

GUDID B066SDC043

A collection of sterile devices including tubing and typically clamps, filters, connectors, and stopcocks, used in a circuit for a cardiopulmonary byp

NOVOSCI CORP.

Cardiopulmonary bypass system tubing set

• Primary Device ID: B066SDC043
• NIH Device Record Key: bd5e5e82-d92c-450d-8dfe-2cb25bc579a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 1/4' X 3/32' X 48' TUBE PACE
• Version Model Number: SDC04
• Catalog Number: SDC04
• Company DUNS: 938289980
• Company Name: NOVOSCI CORP.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com
• Phone: 800-854-0567
• Email: info@novosci.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B066SDC040 [Primary]
HIBCC	B066SDC043 [Package]; Contains: B066SDC040; Package: CASE [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K801401

FDA Product Code

• DWF: Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-09