MediGuide™ H701257

GUDID 05415067012579

Cable Kit

ST. JUDE MEDICAL, INC.

Cardiac mapping system

• Primary Device ID: 05415067012579
• NIH Device Record Key: 4f716b2e-0264-4109-9258-9378e95ef438
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MediGuide™
• Version Model Number: Technology
• Catalog Number: H701257
• 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

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067012579 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120301

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: 2016-03-29

On-Brand Devices [MediGuide™]

• 05415067027085: System
• 05415067024275: Cath Connect, Sensor Enabled
• 05415067023841: System Installation Tool
• 05415067023711: Software Upgrade Kit
• 05415067020550: Magnetic Transmitter Assembly
• 05415067018298: Magnetic Transmitter Assembly
• 05415067016256: Workstation
• 05415067016249: Workstation
• 05415067016027: Magnetic Transmitter Assembly
• 05415067014672: Software Installation
• 05415067013279: ECG Kit
• 05415067013262: Upgrade Kit
• 05415067013002: System Installation Tool
• 05415067012586: Cable Kit
• 05415067012579: Cable Kit
• 05415067012562: Cable Kit
• 05415067012555: Cable Kit
• 05415067012135: Upgrade Kit
• 05415067010995: ECG Cable
• 05415067010933: Cover Proximity Switch
• 05415067009807: Power Supply
• 05415067009791: Power Supply
• 05415067006752: Technology
• 05415067006721: Technology
• 05415067006714: Technology
• 05415067006707: MTAC
• 05415067006691: TSU
• 05415067006684: Technology
• 05415067004697: Technology
• 05415067004680: Connect
• 05415067004604: Technology
• 05415067004314: Magnetic Transmitter Assembly
• 05415067004307: Technology
• 05415067003850: GUIDEWIRE TORQUE CLIP
• 05415067003843: GUIDEWIRE CONNECTOR Electrical Connection for MediGuide Enabled™ Guidewire
• 05415067003836: DS2M031
• 15415067000719: PRS Patch
• 05414734509459: Guidewire Connector