AccessGUDID - DEVICE: CardioMEMS™ (05414734509237)

GUDID

Device Identifier (DI) Information

Brand Name: CardioMEMS™
Version or Model: CM2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CM2000
Company Name: CARDIOMEMS, INC.

Primary DI Number: 05414734509237
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086938409 *Terms of Use

Device Description: PA Sensor and Delivery System

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

GMDN Preferred Term Name

GMDN Definition

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.

FDA Product Code

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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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -18 and 60 Degrees Celsius
Storage Environment Temperature: between 0 and 140 Degrees Fahrenheit
Handling Environment Temperature: between -18 and 60 Degrees Celsius
Handling Environment Temperature: between 0 and 140 Degrees Fahrenheit

Clinically Relevant Size

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Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96bf69e7-6295-4670-982e-cc4e614db479
Public Version Date: April 12, 2018
Public Version Number: 3
DI Record Publish Date: October 29, 2014