CLAB II Plus Amplifier

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems Information Technologies, Inc.

Identity

Trade Name: CLAB II Plus Amplifier FDA UDI
Generic Name: Cardiac catheterization monitoring system FDA UDI
Device Name: ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1 FDA UDI
Model / Reference: 128 Channel FDA UDI
Description: ASSY CLABII PLUS128 AMP 110-240V 50/60HZ, AM 1 FDA UDI

Identifiers

Primary DI / UDI-DI: 00840682119603 FDA UDI
510(k) Number: K130626 FDA UDI
FDA Product Code: DQK FDA UDI
DRR FDA UDI
GMDN Term: Cardiac catheterization monitoring system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.1425 FDA UDI
870.2050 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

CLAB II Plus Amplifier by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 dabcdb98-9f2b-4158-a3c8-8a9ae484aafd 35 fields · synced Jun 8, 2026