PDM Base Station

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems Information Technologies, Inc.

Identity

Trade Name: PDM Base Station FDA UDI
Generic Name: Cardiac electrophysiology analysis system FDA UDI
Device Name: ASSY PDM BASE STATION PLUS CO2 FDA UDI
Model / Reference: Plus FDA UDI
Description: ASSY PDM BASE STATION PLUS CO2 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682119665 FDA UDI
510(k) Number: K130626 FDA UDI
FDA Product Code: DQK FDA UDI
GMDN Term: Cardiac electrophysiology analysis system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 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

FDA UDI

Category: Cardiac catheterization monitoring system Cardiac electrophysiology analysis system

PDM Base Station by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cardiac electrophysiology analysis system.

Pure EP - 5 x Single Jumper Cable Red 0.3m — Biosig Technologies · Class II
Pure EP - Catheter Input Module — Biosig Technologies · Class II
Pure EP - ECG Cable — Biosig Technologies · Class II
Pure EP - 5 x 10 pin Yoked Jumper Cable Blue — Biosig Technologies · Class II
Pure EP - 5 x 10 pin Yoked Jumper Cable White — Biosig Technologies · Class II
Pure EP - Catheter Input Module — Biosig Technologies · Class II
EP-TRACER — CardioTek B.V. · Class II
EMS-XL — Mennen Medical, Inc. · Class II

Cleared under the same submission

K130626 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Ge Medical Systems Information Technologies, Inc.

Sources (1)

FDA UDI f3ce5b1c-e354-48ef-9a67-df1171c4108b 35 fields · synced Jun 8, 2026