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Transvenous Pacing Electrode Tray

FDA UDI

Class II (US FDA UDI)

by Argon Medical Devices, Inc.

Identity

Trade Name
Transvenous Pacing Electrode Tray FDA UDI
Generic Name
Temporary cardiac pacing balloon catheter FDA UDI
Device Name
Transvenous Pacing Electrode Tray w/ Bipolar Pacing Electrode 5F 115cm FDA UDI
Model / Reference
008416A FDA UDI
Description
Transvenous Pacing Electrode Tray w/ Bipolar Pacing Electrode 5F 115cm FDA UDI

Identifiers

Catalog Number
008416A FDA UDI
Primary DI / UDI-DI
00886333217632 FDA UDI
FDA Product Code
OEZ FDA UDI
GMDN Term
Temporary cardiac pacing balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Temporary cardiac pacing balloon catheter

Transvenous Pacing Electrode Tray by Argon Medical Devices, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temporary cardiac pacing balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Argon Medical Devices, Inc.

Sources (1)

  • FDA UDI f0b877d3-9078-4408-b223-0e14bb07b6eb 36 fields · synced Jun 9, 2026