Care Orchestrator Essence 1135709

GUDID 30606959052834

Care Orchestrator Essence, Clinical data collection management information system application software

Respironics, Inc.

Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software Medical equipment clinical data interfacing software

• Primary Device ID: 30606959052834
• NIH Device Record Key: 69ae5cff-3a01-4096-a481-11ccc6b0a80f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care Orchestrator Essence
• Version Model Number: 2.0
• Catalog Number: 1135709
• Company DUNS: 080728314
• Company Name: Respironics, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM
• Phone: +1(724)387-4000
• Email: RESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959052833 [Primary]
GS1	30606959052834 [Package]; Contains: 00606959052833; Package: Multipack [1 Units]; In Commercial Distribution
GS1	40606959052831 [Package]; Contains: 00606959052833; Package: Multipack [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• MNT: Ventilator, continuous, minimal ventilatory support, facility use

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: 2018-11-08
• Device Publish Date: 2018-08-21

On-Brand Devices [Care Orchestrator Essence]

• 00606959053984: Care Orchestrator Essence, Clinical data collection management information system application so
• 30606959052834: Care Orchestrator Essence, Clinical data collection management information system application so
• 00606959062863: Care Orchestrator Essence, Medical equipment clinical data interfacing software