Sjm™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: SJM™ FDA UDI
Generic Name: Cardiac pulse generator programmer FDA UDI
Device Name: Telemetry Wand FDA UDI
Model / Reference: 3630 FDA UDI
Description: Telemetry Wand FDA UDI

Identifiers

Catalog Number: 3630 FDA UDI
Primary DI / UDI-DI: 05414734501668 FDA UDI
FDA Product Code: NIK FDA UDI
GMDN Term: Cardiac pulse generator programmer FDA UDI

Classification

Device Class: Class III FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac pulse generator programmer

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

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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 III	Pending data

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Manufacturer

Manufacturer: St. Jude Medical, Inc.

Sources (1)

FDA UDI ffa6bb68-42e7-49dc-a7f0-315c5498de25 36 fields · synced May 30, 2026