CardioMEMS™ CM2000

GUDID 05414734509237

PA Sensor and Delivery System

CARDIOMEMS, 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 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: 05414734509237
• NIH Device Record Key: 96bf69e7-6295-4670-982e-cc4e614db479
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioMEMS™
• Version Model Number: CM2000
• Catalog Number: CM2000
• Company DUNS: 086938409
• Company Name: CARDIOMEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• 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
• 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
• 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 Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -18 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit
• Handling Environment Temperature: Between 0 Degrees Fahrenheit and 140 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734509237 [Primary]

FDA Product Code

• MOM: System, hemodynamic, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-04-12
• Device Publish Date: 2014-10-29

On-Brand Devices [CardioMEMS™]

• 05415067029331: Hospital Electronics System
• 05414734509800: Patient Electronics System
• 15414734509562: 0.018 in / 260 cm
• 05414734509244: CM3000
• 05414734509237: PA Sensor and Delivery System
• 05414734509176: CM1010
• 05414734509169: CM1000
• 05414734509398: WiFi Adaptor
• 05414734509299: US Power Cord-110V
• 05414734509220: Electronics Travel Case