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Merlin@home™

FDA UDI

Class I (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
Wireless Broadband Kit FDA UDI
Model / Reference
EX1170 FDA UDI
Description
Wireless Broadband Kit FDA UDI

Identifiers

Catalog Number
EX1170 FDA UDI
Primary DI / UDI-DI
05414734504706 FDA UDI
FDA Product Code
DTF FDA UDI
GMDN Term
Transtelephonic implantable pacemaker analysis system FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
870.3730 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

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 I — 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 f8ff5bdc-9743-4a9e-86b5-9c6c58aa5ade 36 fields · synced Jun 8, 2026