DreamMapper App iOS (EMEA)

Basic Information

• Brand Name: DreamMapper App iOS (EMEA)
• Primary DI: 00606959051348
• Version / Model: 2.13
• Catalog Number: 1128264
• Company Name: Respironics, Inc.
• Labeler DUNS: 080728314
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-16
• Public Version: 2
• Public Version Date: 2018-07-06
• Public Version Status: New
• Public Device Record Key: d176462e-b301-41cc-8f7b-6e79a4d0b0ed

Device Description

DreamMapper iOS EU Instance v 2.13

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZD	VENTILATOR, NON-CONTINUOUS (RESPIRATOR)	Anesthesiology	868.5905	2
MNS	VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING	Anesthesiology	868.5895	2
MNT	Ventilator, continuous, minimal ventilatory support, facility use	Anesthesiology	868.5895	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58884	Self-care monitoring/reporting software	An application software program designed for the continual collection and aggregation of a patient's self-care data to promote communication between patient and healthcare provider, to facilitate a patient's self-care by using rules defined during use of the application, and/or to facilitate population monitoring. It is typically used to capture clinical (e.g., blood pressure, weight, and blood glucose), nutritional, and/or exercise information in the home, which may include medication administration information captured from enabled injection devices and data from wearable devices, providing care plan, journal, medication advice, and/or messaging functionalities.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00606959051348	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K152356	000