Reveal LINQ™

FDA UDI

Class II (US FDA UDI)

by Medtronic, Inc.

Identity

Trade Name: Reveal LINQ™ FDA UDI
Generic Name: Implantable cardiac monitor FDA UDI
Device Name: MON LNQ11 REVEAL LINQ USA FDA UDI
Model / Reference: LNQ11 FDA UDI
Description: MON LNQ11 REVEAL LINQ USA FDA UDI

Identifiers

Primary DI / UDI-DI: 00763000562625 FDA UDI
510(k) Number: K212008 FDA UDI
FDA Product Code: DSI FDA UDI
MXD FDA UDI
GMDN Term: Implantable cardiac monitor FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1025 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

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Implantable cardiac monitor

Reveal LINQ™ by Medtronic, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable cardiac monitor.

AngelMed Guardian IMD Model AMSG3-E — AVERTIX MEDICAL INC. · Class III
Jot Dx™ — ST. JUDE MEDICAL, INC. · Class II
LUX-Dx™ Insertable Cardiac Monitor — Boston Scientific · Class II
BioMonitor IV — BIOTRONIK SE & Co. KG · Class II
LUX-Dx II+™ — Boston Scientific · Class II
Confirm Rx™ — ST. JUDE MEDICAL, INC. · Class II
LUX-Dx II™ — Boston Scientific · Class II
BioMonitor III — BIOTRONIK SE & Co. KG · Class II

Cleared under the same submission

K212008 also covers:

Reveal LINQ™ — MEDTRONIC, INC.

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: Medtronic, Inc.

Sources (1)

FDA UDI 838dd49a-dcda-4d5a-beac-cc08f9d5b803 36 fields · synced Jun 6, 2026