Livewire™ D402058

GUDID 05414734216890

ST. JUDE MEDICAL, INC.

Cardiac mapping catheter, percutaneous, single-use

• Primary Device ID: 05414734216890
• NIH Device Record Key: 70a6dda1-68dd-4cc5-853f-e70b53ae5a30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Livewire™
• Version Model Number: Mediguide Enable™
• Catalog Number: D402058
• 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: 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Device Dimensions

• Catheter Gauge: 6 French

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *STORE IN COOL, DARK, DRY PLACE.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734216890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101955

FDA Product Code

• DRF: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-01-25

On-Brand Devices [Livewire™]

• 05414734216890: Mediguide Enable™
• 05414734202770: Steerable Electrophysiology Catheter
• 05414734202763: 402022
• 05414734202657: 401935
• 05414734202640: 401934
• 05414734202633: 401933
• 05414734202626: 401932
• 05414734202596: Livewire BDB™
• 05414734202565: 401914
• 05414734202558: 401908
• 05414734202541: 401905
• 05414734202534: 401904
• 05414734202466: 401781
• 05414734202459: 401780
• 05414734202411: 401654
• 05414734202350: 401648
• 05414734202336: 401606
• 05414734202329: 401603
• 05414734202312: 401600
• 05414734202176: 401572
• 05414734202701: Steerable Electrophysiology Catheter