DreamMapper 1101479

GUDID 00606959047495

DreamMapper Mobile Application Android

Respironics, Inc.

Self-care monitoring/reporting software

• Primary Device ID: 00606959047495
• NIH Device Record Key: b5df1cb9-a2a8-41d6-80cf-1a0211de8cf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper
• Version Model Number: 2.8
• Catalog Number: 1101479
• 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)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com
• Phone: +1(724)744-2500
• Email: respironics.service@philips.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959047495 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• BZD: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

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: 2018-07-06
• Device Publish Date: 2017-06-21

On-Brand Devices [DreamMapper]

• 00606959054295: DreamMapper iOS, China Instance, version 2.17
• 00606959054288: DreamMapper App iOS, Asia-Pacific Instance, version 2.17
• 00606959054271: DreamMapper App iOS, EMEA Instance, version 2.17
• 00606959054264: DreamMapper iOS, North American Instance, version 2.17
• 00606959054257: DreamMapper Android, China Instance, version 2.17
• 00606959054240: DreamMapper Mobile App Android, Asia- Pacific Instance, version 2.17
• 00606959054233: DreamMapper Mobile App Android, EMEA Instance, version 2.17
• 00606959054226: DreamMapper Mobile App Android, North America Instance, version 2.17
• 00606959054219: DreamMapper Web, China Instance, version 2.17
• 00606959054202: DreamMapper Web, Asia-Pacific Instance, Version 2.17
• 00606959054196: DreamMapper Web EMEA Instance, Version 2.17
• 00606959054189: DreamMapper Web North American Instance, Version 2.17
• 00606959047549: DreamMapper App iOS (APAC)
• 00606959047532: DreamMapper Mobile Application iOS EMEA
• 00606959047525: DreamMapper Application iOS
• 00606959047518: DreamMapper Mobile Application Android (APAC)
• 00606959047501: DreamMapper Mobile Application Android (EMEA)
• 00606959047495: DreamMapper Mobile Application Android
• 00606959047488: DreamMapper Web (APAC)
• 00606959047471: DreamMapper Web (EMEA)
• 00606959047464: DreamMapper Web
• 00606959046825: DreamMapper Mobile Application Android (EMEA)
• 00606959046818: DreamMapper Mobile Application iOS EMEA
• 00606959046801: DreamMapper Web (EMEA)
• 00606959046795: DreamMapper Mobile Application Android (APAC)
• 00606959046788: DreamMapper App iOS (APAC)
• 00606959046771: DreamMapper Web (APAC)
• 00606959046764: DreamMapper Web
• 00606959046757: DreamMapper Mobile Application Android
• 00606959046740: DreamMapper Application iOS
• 00606959044418: DreamMapper Mobile Application Android (EMEA)
• 00606959044401: DreamMapper Mobile Application iOS EMEA
• 00606959044395: DreamMapper Web (EMEA)
• 00606959044388: DreamMapper Mobile Application Android (APAC)
• 00606959044371: DreamMapper Web (APAC)
• 00606959044364: DreamMapper Web
• 00606959044357: DreamMapper Mobile Application Android
• 00606959044340: DreamMapper Application iOS
• 00606959044111: DreamMapper App iOS (APAC)
• 00606959042018: DreamMapper Mobile Application iOS EMEA
• 00606959041998: DreamMapper Mobile Application Android (APAC)
• 00606959041981: DreamMapper Application iOS (APAC)
• 00606959041974: DreamMapper Web (APAC)
• 00606959041967: DreamMapper Web
• 00606959041950: DreamMapper Mobile Application Android
• 00606959041943: DreamMapper Application iOS
• 00606959059078: DreamMapper iOS China Instance v 2.23
• 00606959059061: DreamMapper iOS APAC Instance v 2.23
• 00606959059054: DreamMapper iOS EU Instance v 2.23
• 00606959059047: DreamMapper iOS NA Instance v 2.23