DreamMapper App iOS (EMEA) 1128264

GUDID 00606959048577

DreamMapper App iOS (EMEA)

Respironics, Inc.

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

• Primary Device ID: 00606959048577
• NIH Device Record Key: f54a3e3b-9f85-4af0-930b-8bdab032601a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper App iOS (EMEA)
• Version Model Number: 2.9
• Catalog Number: 1128264
• 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	00606959048577 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-04

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

• 00606959051348: DreamMapper iOS EU Instance v 2.13
• 00606959048577: DreamMapper App iOS (EMEA)
• 00606959049949: DreamMapper iOS EU Instance v 2.11
• 00606959049093: DreamMapper iOS EU Instance v 2.10