Assert-IQ™

FDA UDI

Class II (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: Assert-IQ™ FDA UDI
Generic Name: Implantable cardiac monitor FDA UDI
Device Name: 3+ Insertable Cardiac Monitor FDA UDI
Model / Reference: DM5300 FDA UDI
Description: 3+ Insertable Cardiac Monitor FDA UDI

Identifiers

Catalog Number: DM5300 FDA UDI
Primary DI / UDI-DI: 05415067047816 FDA UDI
510(k) Number: K230286 FDA UDI
FDA Product Code: MXC FDA UDI
GMDN Term: Implantable cardiac monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

Similar devices

Also classified as Implantable cardiac monitor.

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LUX-Dx™ Insertable Cardiac Monitor — Boston Scientific · Class II
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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

Cleared under the same submission

K230286 also covers:

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 d8f24eea-ab11-485b-a96a-8ea23df4044e 37 fields · synced May 30, 2026