DEVICE: CardioMEMS™ (05414734509237)

Device Identifier (DI) Information

CardioMEMS™
CM2000
In Commercial Distribution
CM2000
CARDIOMEMS, INC.
05414734509237
GS1

1
086938409 *Terms of Use
PA Sensor and Delivery System
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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.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
MOM System, hemodynamic, implantable
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
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
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify:
Length: 15.0000 Millimeter
Device Size Text, specify: Catheter Length
Width: 2.0000 Millimeter
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Device Record Status

96bf69e7-6295-4670-982e-cc4e614db479
September 25, 2024
7
October 29, 2014
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
Yes
No
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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