SOMNOscreen

GUDID 04250413400492

SOMNOmedics GmbH

Polysomnograph
Primary Device ID04250413400492
NIH Device Record Key576f949a-a4bb-4eb9-a94c-346d3d6d2426
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOscreen
Version Model NumberSSC050
Company DUNS314112173
Company NameSOMNOmedics GmbH
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 Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104250413400492 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNRVentilatory Effort Recorder

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 Date2016-09-22

Devices Manufactured by SOMNOmedics GmbH

04250413402748 - SOMNOwatch plus ACTI2023-12-15
04250413402755 - SOMNOwatch plus ACTI2023-12-15
04250413410781 - SOMNO HD / ECO accessory2023-12-08
04250413410828 - SOMNOscreen ECO EEG 322023-12-08
04250413410835 - SOMNOtouch RESP accessory2023-12-08
04250413410842 - SOMNOtouch RESP accessory2023-12-08
04250413410859 - SOMNOtouch RESP accessory2023-12-08
04250413400522 - SOMNOscreen Plus accessory2023-09-04

Trademark Results [SOMNOscreen]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOMNOSCREEN
SOMNOSCREEN
85748831 4346500 Live/Registered
SOMNOmedics GmbH
2012-10-09
SOMNOSCREEN
SOMNOSCREEN
78151829 not registered Dead/Abandoned
Somnomedics GmbH & Co.
2002-08-07

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