eCareManager 865325

GUDID 00884838106963

Telehealth Center Product License

VISICU, INC.

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• Primary Device ID: 00884838106963
• NIH Device Record Key: 21386bdb-10ab-4275-8506-3a48f7fe2c10
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCareManager
• Version Model Number: 4.6
• Catalog Number: 865325
• Company DUNS: 053869348
• Company Name: VISICU, 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: true
• 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: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com
• Phone: +1 877-374-2872
• Email: eicusupport@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838102910 [Previous]
GS1	00884838106963 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211046

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [eCareManager]

• 00884838099807: 4.3
• 00884838101050: 4.4
• 00884838102910: 4.5
• 00884838106963: Telehealth Center Product License
• 00884838115460: Telehealth Center Product License