TactiSys™

FDA UDI

Class III (US FDA UDI)

by St. Jude Medical, Inc.

Identity

Trade Name: TactiSys™ FDA UDI
Generic Name: Cardiac mapping system computer FDA UDI
Device Name: Display Workstation FDA UDI
Model / Reference: PN-004711 FDA UDI
Description: Display Workstation FDA UDI

Identifiers

Catalog Number: PN-004711 FDA UDI
Primary DI / UDI-DI: 07640157990316 FDA UDI
FDA Product Code: OAE FDA UDI
GMDN Term: Cardiac mapping system computer 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Cardiac mapping system computer

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

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Ablamap® System — Ablacon Inc. · Class II
McKesson Cardiology ECG Management — Change Healthcare Canada Company · Class II
GEMS Win Air — CardioComm Solutions, Inc · Class II

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 a682f352-996f-4cf6-92d3-a0b6e37c0be8 36 fields · synced May 29, 2026