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CardioMEMS™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
CardioMEMS™ FDA UDI
Generic Name
Implantable pulmonary artery pressure monitoring system FDA UDI
Device Name
Positioning Ball FDA UDI
Model / Reference
CM1050 FDA UDI
Description
Positioning Ball FDA UDI

Identifiers

Catalog Number
CM1050 FDA UDI
Primary DI / UDI-DI
05414734509213 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Implantable pulmonary artery pressure monitoring system

CardioMEMS™ by St. Jude Medical, 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

Sources (1)

  • FDA UDI 273ee607-b0af-4c45-8c89-8a43bf2b12a3 36 fields · synced Jun 1, 2026