DreamMapper App iOS (EMEA) 1128264

GUDID 00606959051348

DreamMapper iOS EU Instance v 2.13

Respironics, Inc.

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

• Primary Device ID: 00606959051348
• NIH Device Record Key: d176462e-b301-41cc-8f7b-6e79a4d0b0ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DreamMapper App iOS (EMEA)
• Version Model Number: 2.13
• 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(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	00606959051348 [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: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-16

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