DreamMapper Mobile App Android (EMEA) 1128265

GUDID 00606959048546

DreamMapper Mobile App Android (EMEA)

Respironics, Inc.

Self-care monitoring/reporting software Self-care monitoring/reporting software Self-care monitoring/reporting software
Primary Device ID00606959048546
NIH Device Record Key0df509d8-b3ae-4562-bca7-9b305bd9afb8
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamMapper Mobile App Android (EMEA)
Version Model Number2.9
Catalog Number1128265
Company DUNS080728314
Company NameRespironics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM
Phone+1(724)744-2500
EmailRESPIRONICS.SERVICE@PHILIPS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959048546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNTVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-10-04

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

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.