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Merlin™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Merlin™ FDA UDI
Generic Name
Implantable cardiac device management application software FDA UDI
Device Name
Live Connect Remote Session Engine FDA UDI
Model / Reference
MLC1000 FDA UDI
Description
Live Connect Remote Session Engine FDA UDI

Identifiers

Catalog Number
MLC1000 FDA UDI
Primary DI / UDI-DI
05415067049575 FDA UDI
FDA Product Code
OSR FDA UDI
NKE FDA UDI
LWS FDA UDI
DXY FDA UDI
LWO FDA UDI
LWP FDA UDI
NIK FDA UDI
GMDN Term
Implantable cardiac device management application software FDA UDI

Classification

Device Class
Class III FDA UDI
Regulation Number
870.3610 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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 cardiac device management application software

Merlin™ by St. Jude Medical, Inc. — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Implantable cardiac device management application software.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI be321df1-63e1-4b20-aa1f-1e4f95a19b47 35 fields · synced May 30, 2026