Care Orchestrator Japan 1136532

GUDID 00606959050013

Care Orchestrator Japan

Respironics, Inc.

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

• Primary Device ID: 00606959050013
• NIH Device Record Key: 5208a71b-3dda-4268-915c-e9fb9d261348
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Care Orchestrator Japan
• Version Model Number: 1.12
• Catalog Number: 1136532
• 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	00606959050013 [Primary]

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: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-02-09

On-Brand Devices [Care Orchestrator Japan]

• 00606959050693: Care Orchestrator Japan
• 00606959050013: Care Orchestrator Japan
• 00606959049727: Care Orchestrator Japan