CardioMEMS™ CM1010

GUDID 05414734509176

CARDIOMEMS, INC.

Implantable pulmonary artery pressure monitoring system

• Primary Device ID: 05414734509176
• NIH Device Record Key: 0563d051-25db-4d6c-9acc-0f51fe269102
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CardioMEMS™
• Version Model Number: CM1010
• Catalog Number: CM1010
• 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: 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

Operating and Storage Conditions

• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit
• Handling Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry.
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Temperature: Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	05414734509176 [Primary]

FDA Product Code

• MOM: System, hemodynamic, implantable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• 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