SOMNOscreen Headbox

GUDID 04250413402014

SOMNOmedics GmbH

Polysomnograph
Primary Device ID04250413402014
NIH Device Record Keya5053e75-e33e-48c8-828a-739ee3777973
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOscreen Headbox
Version Model NumberSEN040
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
GS104250413402014 [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 Date2017-05-22

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

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