Vital Sync

GUDID 10884521757127

Virtual Patient Monitoring Platform and Informatics Manager v2.6

Covidien LP

Clinical information system web-based application software

• Primary Device ID: 10884521757127
• NIH Device Record Key: 853149b4-4254-4f15-9b60-0e00e4a6d32a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Sync
• Version Model Number: Vital Sync v2.6
• Company DUNS: 058614483
• Company Name: Covidien LP
• 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(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521757127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160718

FDA Product Code

• DRG: TRANSMITTERS AND RECEIVERS, PHYSIOLOGICAL SIGNAL, RADIOFREQUENCY

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-08-13
• Device Publish Date: 2017-11-06

On-Brand Devices [Vital Sync]

• 10884521795273: VITAL SYNC V2 SOFTWARE
• 10884521812208: VITAL SYNC V2 SOFTWARE
• 10884521809246: VITAL SYNC Mobile Access V2.0.0
• 10884521810334: VITAL SYNC V2 SOFTWARE
• 10884521815810: Vital Sync Mobile Application Software
• 10884521757127: Virtual Patient Monitoring Platform and Informatics Manager v2.6
• 10884521702882: Virtual Patient Monitoring Platform and Informatics Manager v2.5.1/v2.6.2
• 10884521818965: VITAL SYNC V3 SOFTWARE
• 10884521823372: VITAL SYNC V2 SOFTWARE
• 10884521706675: Spontaneous Breathing Trial and Weaning Readiness Application v1.0
• 10884521706668: Early Warning Score Application v1.0
• 10884521762633: Vital Sync Weaning Readiness and Spontaneous Breathing Trial Monitoring Application v1 Software
• 10884521762626: Vital Sync Early Warning Score Application v1 Software with OUS Support
• 10884521829848: VITAL SYNC V3 SOFTWARE
• 10884521806740: VITAL SYNC V2 SOFTWARE
• 10884521780668: VITAL SYNC V2 SOFTWARE
• 10884521762619: VITAL SYNC V2 SOFTWARE
• 10884521795150: Ventilation Dashboard v1.0 Excess Use Subscription
• 10884521795143: Ventilation Dashboard v1.0 Subscription
• 10884521829855: VITAL SYNC V2 SOFTWARE
• 10884521835962: VITAL SYNC V2 SOFTWARE
• 10884521835870: VITAL SYNC V3 SOFTWARE
• 10884521844933: VITAL SYNC V3 SOFTWARE
• 10884521845176: VITAL SYNC V2 SOFTWARE
• 10884521844940: VITAL SYNC V3 SOFTWARE
• 10884521847675: VITAL SYNC V2 SOFTWARE
• 10884521849358: VITAL SYNC V4 SOFTWARE