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Merlin@home™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name
Merlin@home™ FDA UDI
Generic Name
Transtelephonic implantable pacemaker analysis system FDA UDI
Device Name
Transmitter FDA UDI
Model / Reference
EX1100 FDA UDI
Description
Transmitter FDA UDI

Identifiers

Catalog Number
EX1100 FDA UDI
Primary DI / UDI-DI
05414734504782 FDA UDI
FDA Product Code
NVZ FDA UDI
NIK FDA UDI
LWP FDA UDI
OSR FDA UDI
LWO FDA UDI
NKE FDA UDI
DXY FDA UDI
LWS FDA UDI
GMDN Term
Transtelephonic implantable pacemaker analysis system 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Transtelephonic implantable pacemaker analysis system

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

Similar devices

Also classified as Transtelephonic implantable pacemaker analysis system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
St. Jude Medical, Inc.

Sources (1)

  • FDA UDI 4f1a3326-1dbc-4e4b-9f77-caab40ecbeaf 36 fields · synced May 30, 2026