EnSite Precision™ H702496

GUDID 05415067026125

Software Installation, v.2.0.0

ST. JUDE MEDICAL, INC.

Cardiac mapping system application software

• Primary Device ID: 05415067026125
• NIH Device Record Key: c0c8cdf5-ed73-4613-8e48-0cf05ddad947
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EnSite Precision™
• Version Model Number: H702496
• Catalog Number: H702496
• 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
• 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
• 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
• 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
• 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
• Phone: +1(855)478-5833
• Email: customerservice@sjm.com
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry. Do not use if package is damaged.
• 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	05415067026125 [Primary]

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: 3
• Public Version Date: 2019-07-09
• 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