WorkMate Claris™ H800012

GUDID 05415067035615

Software Upgrade Kit

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system Cardiac catheterization monitoring system

• Primary Device ID: 05415067035615
• NIH Device Record Key: 0398987a-9534-4d29-8b7d-0d2efafa752a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WorkMate Claris™
• Version Model Number: H800012
• Catalog Number: H800012
• Company DUNS: 149818952
• Company Name: ST. JUDE MEDICAL, INC.
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• 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: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067035615 [Primary]

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2021-03-30
• Device Publish Date: 2021-03-22

On-Brand Devices [WorkMate Claris™]

• 05415067023209: Software Upgrade Kit
• 05415067020185: Software Upgrade Kit
• 05415067018090: System
• 05415067017031: WorkMate Claris System Display Plus w/o EP-4
• 05415067009777: H700977
• 05415067001610: System
• 05415067001597: IBP Cable, For Use With Argon DTXPlus™
• 05415067001580: System
• 05415067001573: System
• 05415067001566: System
• 05415067001559: IBP Cable, For Use With Smiths Medical TranStar™ MX950
• 05415067001542: System
• 05415067001535: System
• 05415067001528: System
• 05415067001511: System
• 05415067001504: H700150
• 05415067001382: H700138
• 05415067001337: ECG Cable Set, Radiolucent
• 05415067001313: H700131
• 05415067001306: System
• 05415067001290: System
• 05415067001283: System
• 05415067001252: System
• 05415067001245: System
• 05415067001238: System
• 05415067035615: Software Upgrade Kit
• 05415067042385: Software Upgrade Kit
• 05415067042378: Software Upgrade Kit
• 05415067047212: Software Upgrade Kit
• 05415067047182: Z620 Software Upgrade Kit
• 05415067047175: Z440 Software Upgrade Kit
• 05415067001696: Amplifier