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Tapsystem

FDA UDI

Class III (US FDA UDI)

by Cardio Command

Identity

Trade Name
Tapsystem FDA UDI
Generic Name
External pacemaker, transoesophageal pacing FDA UDI
Device Name
A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit). FDA UDI
Model / Reference
2A, unpackaged FDA UDI
Description
A pulse generator system for the treatment of cardiac dysrhythmias, (unpackaged unit). FDA UDI

Identifiers

Catalog Number
8002A FDA UDI
Primary DI / UDI-DI
00856233005066 FDA UDI
PMA Number
P840002 FDA UDI
FDA Product Code
LPA FDA UDI
GMDN Term
External pacemaker, transoesophageal pacing FDA UDI

Classification

Device Class
Class III 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: External pacemaker, transoesophageal pacing

Tapsystem by Cardio Command — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External pacemaker, transoesophageal pacing.

Cleared under the same submission

P840002 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cardio Command

Sources (1)

  • FDA UDI 0eb00822-b96a-4777-bd6e-51480b423171 37 fields · synced May 30, 2026