Care Orchestrator 1136548

GUDID 00606959052482

Care Orchestrator Slovakia

Respironics, Inc.

Medical equipment clinical data interfacing software

• Primary Device ID: 00606959052482
• NIH Device Record Key: 6ec14bef-5412-4584-bef8-f7dfb8d6a810
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care Orchestrator
• Version Model Number: 1.15
• Catalog Number: 1136548
• 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	00606959052482 [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: 2
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-06-15

On-Brand Devices [Care Orchestrator]

• 00606959054790: Care Orchestrator, Clinical data collection management information system application software
• 00606959053922: Care Orchestrator, Clinical data collection management information system application software
• 00606959053533: Care Orchestrator, Clinical data collection management information system application software
• 00606959052871: Care Orchestrator India
• 00606959052499: Care Orchestrator Czech Republic
• 00606959052482: Care Orchestrator Slovakia
• 00606959052468: Care Orchestrator US and Australia, Clinical data collection management information system appli
• 00606959052451: Care Orchestrator Belgium
• 00606959052444: Care Orchestrator Denmark
• 00606959052437: Care Orchestrator Netherlands
• 00606959052420: Care Orchestrator Japan
• 00606959052253: Care Orchestrator Belgium
• 00606959052246: Care Orchestrator Denmark
• 00606959052239: Care Orchestrator Software, Netherlands
• 00606959052222: Care Orchestrator Japan
• 00606959050044: Care Orchestrator
• 00606959049345: Care Orchestrator
• 00606959048904: Care Orchestrator
• 00606959048164: Care Orchestrator
• 00606959047952: Care Orchestrator
• 00606959047426: Care Orchestrator
• 00606959046979: Care Orchestrator
• 00606959045248: Care Orchestrator
• 00606959042650: Care Orchestrator
• 00606959038745: Care Orchestrator (Sapphire)
• 00606959056084: Care Orchestrator, Medical equipment clinical data interfacing software
• 00606959056329: Care Orchestrator, Medical equipment clinical data interfacing software
• 00606959052215: Care Orchestrator
• 00606959056909: Care Orchestrator, Medical equipment clinical data interfacing software
• 00606959058163: 1.25
• 00606959059351: 1.26
• 00606959059672: 1.27
• 00606959060432: 1.28
• 00606959057760: Care Orchestrator, Medical equipment clinical data interfacing software
• 00606959057500: Care Orchestrator, Medical equipment clinical data interfacing software
• 00606959055414: Care Orchestrator, Clinical data collection management information system application software
• 00606959044203: Care Orchestrator
• 00606959049840: Care Orchestrator