CardioMEMS™ CM3150

GUDID 05415067034731

Hospital System Cart

ST. JUDE MEDICAL, INC.

Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system Implantable pulmonary artery pressure monitoring system

• Primary Device ID: 05415067034731
• NIH Device Record Key: 52032999-a618-4cb1-a8bf-82303dccd20e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioMEMS™
• Version Model Number: CM3150
• Catalog Number: CM3150
• 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
• 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

• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05415067034731 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P100045

FDA Product Code

• MOM: System, hemodynamic, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-05
• Device Publish Date: 2022-04-27

On-Brand Devices [CardioMEMS™]

• 05415067034915: Power Cord
• 05415067034731: Hospital System Cart
• 05415067034724: Hospital System
• 05414734510257: Power Cord Clip
• 05414734509978: Fabric Cover
• 05414734509923: Travel Case
• 05414734509916: Power Supply
• 05414734509909: Power Cord Clip
• 05414734509312: Power Supply
• 05414734509282: Printer Paper
• 05414734509275: Printer Power Cables
• 05414734509251: Printer
• 05414734509213: Positioning Ball
• 05414734509190: Pillow
• 05414734509183: User button
• 05414734509268: Printer Serial Cables
• 05414734509206: GSM Antenna