Mobile Care

GUDID 00840682106498

GE Healthcare Finland Oy

Patient monitoring system central station monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor Centralized patient monitor

• Primary Device ID: 00840682106498
• NIH Device Record Key: 63af9ec9-cb69-4779-a6ef-61adab0295f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mobile Care
• Version Model Number: Web Viewer
• Company DUNS: 401966697
• Company Name: GE Healthcare Finland Oy
• 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)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx
• Phone: +1(800)558-5120
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682106498 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033078

FDA Product Code

• MSX: SYSTEM,NETWORK AND COMMUNICATION,PHYSIOLOGICAL MONITORS

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: 2016-06-21

Devices Manufactured by GE Healthcare Finland Oy

• 00195278697165 - PORTRAIT HSWXB: 2024-05-08 Portrait HSWXB Medical Software
• 00195278713193 - Portrait HUBXB: 2024-05-08 Portrait Mobile Patient Monitor Hardware HUBXB
• 00195278229229 - PORTRAIT RRP01: 2024-01-03 BODY-WORN RESP ELECTRODE PATCH
• 00195278699916 - PORTRAIT AAB01: 2023-11-03 Portrait AAB01 SpO2 attachment accessory band, PKG of 30 PCS
• 00195278699923 - PORTRAIT MMP01: 2023-11-03 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS
• 00195278093998 - PORTRAIT HUB01: 2023-09-11 HUB, AMBULATORY HUB DEVICE ASSEMBLY
• 00195278094001 - PORTRAIT BCH01: 2023-09-11 CHARGER, AMBULATORY CHARGER FINAL DEVICE ASSEMBLY
• 00195278110435 - PORTRAIT MMP01: 2023-09-11 Portrait MMP01 Mobile Patient Monitor Pouch, PKG of 30 PCS