MURAL PERINATAL SURVEILLANCE K1770PTED

GUDID 00195278726391

MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system Patient health record information system

• Primary Device ID: 00195278726391
• NIH Device Record Key: 3aaf4820-e904-4877-b674-dd9b14064532
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MURAL PERINATAL SURVEILLANCE
• Version Model Number: 2.2
• Catalog Number: K1770PTED
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278726391 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220732

FDA Product Code

• HGM: System, monitoring, perinatal

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: 2024-06-10
• Device Publish Date: 2024-05-31

Devices Manufactured by GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

• 00195278726391 - MURAL PERINATAL SURVEILLANCE: 2024-06-10MD MURAL PERINATAL SURVEILLANCE 2.2 MEDICAL DEVICE
• 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