DreamMapper Mobile App Android (EMEA) 1128265

GUDID 00606959049062

DreamMapper Android EU Instance v 2.10

Respironics, Inc.

Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software

• Primary Device ID: 00606959049062
• NIH Device Record Key: 414c3270-4b3e-412f-a446-20090656f788
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper Mobile App Android (EMEA)
• Version Model Number: 2.10
• Catalog Number: 1128265
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00606959049062 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152356

FDA Product Code

• MNS: Ventilator, continuous, non-life-supporting

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-26
• Device Publish Date: 2020-10-16

On-Brand Devices [DreamMapper Mobile App Android (EMEA)]

• 00606959051300: DreamMapper Android EU Instance v 2.13
• 00606959048546: DreamMapper Mobile App Android (EMEA)
• 00606959042025: DreamMapper Mobile Application Android (EMEA)
• 00606959049901: DreamMapper Android EU Instance v 2.11
• 00606959049062: DreamMapper Android EU Instance v 2.10