DreamMapper App iOS 1101478

GUDID 00606959051331

DreamMapper iOS NA Instance v 2.13

Respironics, Inc.

Self-care monitoring/reporting software

• Primary Device ID: 00606959051331
• NIH Device Record Key: cce0b091-9b83-44cb-8bb2-13154222edad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper App iOS
• Version Model Number: 2.13
• Catalog Number: 1101478
• 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(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	00606959051331 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-16

On-Brand Devices [DreamMapper App iOS]

• 00606959051331: DreamMapper iOS NA Instance v 2.13
• 00606959048560: DreamMapper App iOS
• 00606959049932: DreamMapper iOS NA Instance v 2.11
• 00606959049086: DreamMapper iOS NA Instance v 2.10