WorkMate Claris™ H701809

GUDID 05415067018090

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 05415067018090
• NIH Device Record Key: 47e2c0c4-fa42-46c1-92f3-e4923558ccf0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WorkMate Claris™
• Version Model Number: System
• Catalog Number: H701809
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067018090 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132073

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-07-22
• Device Publish Date: 2015-08-25

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