MLCL Upgrade 5896597

GUDID 00195278516015

Upgrade Kit MLCL V8.0

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiac electrophysiology analysis system

• Primary Device ID: 00195278516015
• NIH Device Record Key: 08850881-2eaa-41ee-9849-8ae2e405bb55
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLCL Upgrade
• Version Model Number: AltiX
• Catalog Number: 5896597
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278516015 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213972

FDA Product Code

• DQK: Computer, diagnostic, programmable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-05-09
• Device Publish Date: 2022-05-01

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 00195278726391 - MURAL PERINATAL SURVEILLANCE: 2024-06-10 MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE
• 00195278561312 - Portrait VSM: 2024-05-13 Portrait VSM ATO MODEL
• 00195278656681 - Portrait CVAXB: 2024-05-08 Portrait Central Viewer Application Installer v1.1.0
• 00195278659446 - Portrait CSSXB: 2024-05-08 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.1.0
• 00195278789846 - Mural Clinical Viewer: 2024-03-21 MD Mural Clinical Viewer 1.2 MEDICAL DEVICE
• 00840682139250 - Portrait CAU01: 2023-10-13 Portrait Clinical Alarming Unit CAU01
• 00195278330413 - Portrait CVA01: 2023-09-11 PORTRAIT CENTRAL STATION INSTALLATION SOFTWARE V1.0.2
• 00195278341129 - Portrait CSS01: 2023-09-11 PORTRAIT CORE SERVICES INSTALLATION SOFTWARE V1.0.3