TubingCRF CRF-TUBE

GUDID 10811746030391

CRF Tubing Set

CAMBRIDGE INTERVENTIONAL LLC

Radio-frequency ablation system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system Cooling utility supply system

• Primary Device ID: 10811746030391
• NIH Device Record Key: e8d95d0c-dd93-4d5b-ae8c-42aa91cd6d7e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TubingCRF
• Version Model Number: CRF-TUBE
• Catalog Number: CRF-TUBE
• Company DUNS: 080897872
• Company Name: CAMBRIDGE INTERVENTIONAL 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com
• Phone: 781-221-5300
• Email: info@cambint.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00811746030394 [Primary]
GS1	10811746030391 [Package]; Contains: 00811746030394; Package: [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192715

FDA Product Code

• GEI: Electrosurgical, Cutting & Coagulation & Accessories

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-08
• Device Publish Date: 2020-04-30

Devices Manufactured by CAMBRIDGE INTERVENTIONAL LLC

• 00811746033159 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033166 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033173 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033180 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033197 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033203 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033210 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit
• 00811746033227 - ProcedureKitCRF: 2023-08-08 CRF Procedure Kit