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CardioMEMS™

FDA UDI

Class III (US FDA UDI)

by Cardiomems, Inc.

Identity

Trade Name
CardioMEMS™ FDA UDI
Generic Name
Implantable pulmonary artery pressure monitoring system FDA UDI
Model / Reference
CM1010 FDA UDI

Identifiers

Catalog Number
CM1010 FDA UDI
Primary DI / UDI-DI
05414734509176 FDA UDI
FDA Product Code
MOM FDA UDI
GMDN Term
Implantable pulmonary artery pressure monitoring system FDA UDI

Classification

Device Class
Class III FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Implantable pulmonary artery pressure monitoring system

CardioMEMS™ by Cardiomems, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable pulmonary artery pressure monitoring system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardiomems, Inc.

Sources (1)

  • FDA UDI 0563d051-25db-4d6c-9acc-0f51fe269102 35 fields · synced Jun 8, 2026