DreamMapper Web China Instance v 2.11 1136946

GUDID 00606959049888

DreamMapper Web China Instance v 2.11

Respironics, Inc.

Self-care monitoring/reporting software Self-care monitoring/reporting software
Primary Device ID00606959049888
NIH Device Record Keyb7aabe5f-8f31-45c1-85ac-9c8313d1ab4d
Commercial Distribution StatusIn Commercial Distribution
Brand NameDreamMapper Web China Instance v 2.11
Version Model Number2.11
Catalog Number1136946
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(999)999-9999
Emailxx@xx.xx
Phone+1(999)999-9999
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100606959049888 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-26
Device Publish Date2019-04-18

Devices Manufactured by Respironics, Inc.

00606959051942 - Trilogy Evo2022-05-23 Trilogy Evo, USA
00606959417540 - DreamStation2022-01-10 Micro-Flexible Heated 12mm Tube
00606959060135 - Therapy Mask 31002021-12-16 Medium Wide, Therapy Mask 3100 Silicone
00606959060098 - Therapy Mask 31002021-11-04
00606959060104 - Therapy Mask 31002021-11-04
00606959060128 - Therapy Mask 31002021-11-04
00606959063082 - DreamStation 22021-11-04
00606959063228 - DreamStation 22021-11-04

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