MLCL Client Software 5889605

GUDID 00195278507525

Software Medical Device GE Client Software V8.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac catheterization monitoring system
Primary Device ID00195278507525
NIH Device Record Keyea34cd94-3ebe-48be-bddd-5f86e63b5025
Commercial Distribution StatusIn Commercial Distribution
Brand NameMLCL Client Software
Version Model NumberAltiX
Catalog Number5889605
Company DUNS006580799
Company NameGE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100195278507525 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQKComputer, diagnostic, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-09
Device Publish Date2022-05-01

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

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00840682118910 - NA2025-05-02 Y-ADAPTER 1 TB BAYONET MALE TO 2 TB DINACLICK FEM, SINGLE
00840682188968 - MLCL Upgrade2025-04-21 Upgrade Kit MLCL V7.1
00840682124669 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 2.4M
00840682124683 - NA2025-04-18 ASSY CARESCAPE ONE NIBP HOSE NEONATAL 2T NEO-SNAP 3.6M
00195278421449 - CAM2025-04-15 CAM 14 - MDR
00195278421456 - CAM2025-04-15 CAM HD - MDR
00195278364661 - CardioSoft2025-04-02 CARDIOSOFT V7.0 SP7.2

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