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GE Client Software

FDA UDI

Class II (US FDA UDI)

by Ge Medical Systems Information Technologies, Inc.

Identity

Trade Name
GE Client Software FDA UDI
Generic Name
Cardiac catheterization monitoring system FDA UDI
Device Name
Software Medical Device GE Client Software V7.0 FDA UDI
Model / Reference
A1 FDA UDI
Description
Software Medical Device GE Client Software V7.0 FDA UDI

Identifiers

Primary DI / UDI-DI
00840682145763 FDA UDI
510(k) Number
K130626 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Cardiac catheterization monitoring system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

GE Client Software by Ge Medical Systems Information Technologies, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K130626 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ge Medical Systems Information Technologies, Inc.

Sources (1)

  • FDA UDI cc9c360b-78a9-4e48-a163-3ad5ae909d93 35 fields · synced Jun 8, 2026