DEVICE: CardioMEMS™ (05414734509237)
Device Identifier (DI) Information
CardioMEMS™
CM2000
In Commercial Distribution
CM2000
CARDIOMEMS, INC.
CM2000
In Commercial Distribution
CM2000
CARDIOMEMS, INC.
PA Sensor and Delivery System
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
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.
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MOM | System, hemodynamic, implantable |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Temperature: between 0 and 140 Degrees Fahrenheit |
Handling Environment Temperature: between -18 and 60 Degrees Celsius |
Storage Environment Temperature: between -18 and 60 Degrees Celsius |
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: |
Length: 15.0000 Millimeter |
Device Size Text, specify: Catheter Length |
Width: 2.0000 Millimeter |
Device Record Status
96bf69e7-6295-4670-982e-cc4e614db479
September 25, 2024
7
October 29, 2014
September 25, 2024
7
October 29, 2014
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com