DreamMapper App iOS (APAC) 1127959

GUDID 00606959049109

DreamMapper iOS APAC 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 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: 00606959049109
• NIH Device Record Key: 0bdc1cc9-b9ac-4ccb-acd7-e551070b33ad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper App iOS (APAC)
• Version Model Number: 2.10
• Catalog Number: 1127959
• 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	00606959049109 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-15
• Device Publish Date: 2020-10-07

On-Brand Devices [DreamMapper App iOS (APAC)]

• 00606959051355: DreamMapper iOS APAC Instance v 2.13
• 00606959048584: DreamMapper App iOS (APAC)
• 00606959049956: DreamMapper iOS APAC Instance v 2.11
• 00606959049109: DreamMapper iOS APAC Instance v 2.10