CardioMEMS™

Basic Information

• Brand Name: CardioMEMS™
• Primary DI: 05414734509176
• Version / Model: CM1010
• Catalog Number: CM1010
• Company Name: CARDIOMEMS, INC.
• Labeler DUNS: 086938409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-10-29
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 0563d051-25db-4d6c-9acc-0f51fe269102

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MOM	System, hemodynamic, implantable	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
61178	Implantable pulmonary artery pressure monitoring system	An assembly of devices intended for regular (e.g., daily) measurement and recording of pulmonary artery pressures, to assist monitoring and treatment of a heart disease patient at high-risk of heart failure. It includes a sensor intended to be implanted in the pulmonary artery, an external monitoring system(s), information software, and typically devices associated with implantation. The monitoring system(s) are intended to wirelessly power and interrogate the implanted sensor via an antenna, and display/record/communicate arterial blood pressure information (e.g., systolic, diastolic and mean pressures, heart rate). It is intended for monitoring in both the home and healthcare facility.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05414734509176	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 93 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep dry.
• Type: Storage Environment Temperature
• Temperature Range: -25 – 70 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit