MARS

GUDID 00840682100069

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Electrocardiographic long-term ambulatory recording analyser application software

• Primary Device ID: 00840682100069
• NIH Device Record Key: 4e6883eb-89fb-41d0-b7ea-c5db3668dd72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MARS
• Version Model Number: V8
• Company DUNS: 784985108
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)558-7044
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682100069 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093141

FDA Product Code

• DQK: COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-05-06

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 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
• 00195278577559 - Mural Clinical Viewer: 2023-07-24 MD Mural Clinical Viewer MEDICAL DEVICE
• 00195278571342 - ONE-CUF: 2023-05-24 ONE-CUF, SMALL ADULT, 1 TB BAYONET, 17 - 25 CM, SINGLE
• 00195278571359 - ONE-CUF: 2023-05-24 ONE-CUF, INFANT, 1 TB BAYONET, 08 - 13 CM SINGLE
• 00195278571366 - ONE-CUF: 2023-05-24 ONE-CUF, ADULT LONG, DINACLICK 5 , 23 - 33 CM, SINGLE