WorkMate™ H700119

GUDID 05415067001191

Module

ST. JUDE MEDICAL, INC.

Cardiac catheterization monitoring system

• Primary Device ID: 05415067001191
• NIH Device Record Key: 84a58032-5738-43fb-beb9-5279b5b91b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WorkMate™
• Version Model Number: Scribe™ Module
• Catalog Number: H700119
• 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: false
• Serial Number: true
• 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

• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067001191 [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: 2016-03-28

On-Brand Devices [WorkMate™]

• 05415067010605: Display Workstation
• 05415067001634: Generic Stimulator Cable
• 05415067001214: Module
• 05415067001207: Module
• 05415067001191: Module
• 05415067001184: Module
• 05415067001160: Module
• 05415067000897: Claris™
• 05415067000880: Claris™