Confirm Rx™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Confirm Rx™ FDA UDI
Generic Name: Implantable cardiac monitor FDA UDI
Device Name: Insertable Cardiac Monitor FDA UDI
Model / Reference: DM3500 FDA UDI
Description: Insertable Cardiac Monitor FDA UDI

Identifiers

Catalog Number: DM3500 FDA UDI
Primary DI / UDI-DI: 05415067027320 FDA UDI
FDA Product Code: DSI FDA UDI
MXC FDA UDI
GMDN Term: Implantable cardiac monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1025 FDA UDI
870.2800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Implantable cardiac monitor

Confirm Rx™ by St. Jude Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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LINQ II™ — MEDTRONIC, INC. · Class II
BioMonitor IV — BIOTRONIK SE & Co. KG · Class II
LUX-Dx II+™ — Boston Scientific · Class II
LUX-Dx II™ — Boston Scientific · Class II
LINQ II™ — MEDTRONIC, INC. · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI ce568a40-e6bc-4a4d-b579-c273e9ab4102 36 fields · synced May 31, 2026