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

• 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