EnSite Precision™ EN0020-P

GUDID 15415067025934

Surface Electrode Kit

ST. JUDE MEDICAL, INC.

Cardiac mapping system reference patch

• Primary Device ID: 15415067025934
• NIH Device Record Key: 77318a4e-07ae-42d0-b210-6b079c9a1d75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnSite Precision™
• Version Model Number: EN0020-P
• Catalog Number: EN0020-P
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067025937 [Primary]
GS1	15415067025934 [Package]; Contains: 05415067025937; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160210

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: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-12-20

On-Brand Devices [EnSite Precision™]

• 05415067030382: Adjustable Field Frame Bracket
• 05415067030085: Software Installation
• 05415067027580: Extended Field Frame Bracket
• 05415067027528: Field Frame Storage Bracket
• 05415067026316: Bedrail Mount Kit
• 05415067026309: Power Supply Kit
• 05415067026279: Software Installation, v.1.0.1
• 05415067026125: Software Installation, v.2.0.0
• 05415067026118: Software Installation, 30 day trial, v.2.0.0
• 15415067025934: Surface Electrode Kit
• 05415067025265: Patient Reference Sensor
• 05415067024756: Link
• 05415067024725: Field Frame Bracket
• 05415067024718: Field Frame Cable
• 05415067024701: Module
• 05415067024695: Field Frame
• 05415067025937: Surface Electrode Kit
• 05415067033178: Software Installation
• 05415067032355: Surface Electrode Kit
• 05415067024732: Module
• 15415067041712: Surface Electrode Kit
• 05415067046185: Software Upgrade
• 05415067035004: Software Installation
• 05415067046802: Software Upgrade