eCareManager System 865325

GUDID 00884838059368

Telehealth Center Product License 4.0

VISICU, INC.

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• Primary Device ID: 00884838059368
• NIH Device Record Key: e257e456-2e36-446d-946a-667a9c85be84
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: eCareManager System
• Version Model Number: 4.0
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com
• Phone: +1877-374-2872
• Email: eicusupport@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884838059368 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K012171

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-09-20

On-Brand Devices [eCareManager System]

• 00884838087453: 4.2
• 00884838059832: Telehealth Center Product License 4.1
• 00884838059368: Telehealth Center Product License 4.0