ViewMate™ H701336

GUDID 05415067013361

Ultrasound Console

ST. JUDE MEDICAL, INC.

General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system General-purpose ultrasound imaging system

• Primary Device ID: 05415067013361
• NIH Device Record Key: 8d536ff4-7a50-4251-9183-ba8ef137d247
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ViewMate™
• Version Model Number: H701336
• Catalog Number: H701336
• 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
• 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
• 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.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067013361 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151175

FDA Product Code

• IYN: System, imaging, pulsed doppler, ultrasonic
• IYO: System, imaging, pulsed echo, ultrasonic

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: 2018-12-24
• Device Publish Date: 2016-04-25

On-Brand Devices [ViewMate™]

• 05415067030733: Software Upgrade
• 05415067013361: Ultrasound Console