Vital Sync VITALSYNCSW01

GUDID 10884521795273

VITAL SYNC V2 SOFTWARE

Covidien LP

Clinical information system web-based application software

• Primary Device ID: 10884521795273
• NIH Device Record Key: 7600a1ae-b7c9-46e2-9f9f-488a4c855de6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vital Sync
• Version Model Number: VITALSYNCSW01
• Catalog Number: VITALSYNCSW01
• 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

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *No

Device Identifiers

Device Issuing Agency	Device ID
GS1	10884521795273 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-10-07
• Device Publish Date: 2019-09-28

On-Brand Devices [Vital Sync]

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• 10884521702882: Virtual Patient Monitoring Platform and Informatics Manager v2.5.1/v2.6.2
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• 10884521706668: Early Warning Score Application v1.0
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• 10884521844940: VITAL SYNC V3 SOFTWARE
• 10884521847675: VITAL SYNC V2 SOFTWARE
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• 10884521847569: VITAL SYNC V3 SOFTWARE