Care Orchestrator Essence Software 1135709

GUDID 00606959055919

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

Respironics, Inc.

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• Primary Device ID: 00606959055919
• NIH Device Record Key: 7cdb7567-7ba8-4eb2-af7c-37cd0f242179
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care Orchestrator Essence Software
• Version Model Number: 2.2
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959055919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• CBK: VENTILATOR, CONTINUOUS, FACILITY USE

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: 2019-09-04
• Device Publish Date: 2019-08-27

On-Brand Devices [Care Orchestrator Essence Software]

• 00606959059085: Care Orchestrator Essence, Clinical data collection management information system application so
• 00606959059689: Care Orchestrator Essence, Clinical data collection management information system application so
• 00606959055919: Care Orchestrator Essence, Clinical data collection management information system application so
• 00606959060449: Care Orchestrator Essence, Clinical data collection management information system application so