Portrait CAU01 2102549-001

GUDID 00840682139250

Portrait Clinical Alarming Unit CAU01

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm Physiologic monitoring system alarm

• Primary Device ID: 00840682139250
• NIH Device Record Key: 272e7577-3999-4092-9de2-c11df457a58b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Portrait CAU01
• Version Model Number: CAU01
• Catalog Number: 2102549-001
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682139250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230626

FDA Product Code

• DQA: Oximeter

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: 2023-10-13
• Device Publish Date: 2023-10-05

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: 2023-10-13Portrait Clinical Alarming Unit CAU01
• 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