Care Orchestrator Belgium 1136542

GUDID 00606959050723

Care Orchestrator Belgium

Respironics, Inc.

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

• Primary Device ID: 00606959050723
• NIH Device Record Key: 85f7ebc5-ebbd-42ab-a6f7-59fec7adb1ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care Orchestrator Belgium
• Version Model Number: 1.13
• Catalog Number: 1136542
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx
• Phone: +1(999)999-9999
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959050723 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• NOU: CONTINUOUS, VENTILATOR, HOME 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: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-04-16

On-Brand Devices [Care Orchestrator Belgium]

• 00606959050723: Care Orchestrator Belgium
• 00606959050051: Care Orchestrator Belgium