SOMNOscreen plus Accessory

GUDID 00833166000405

SOMNOmedics GmbH

Polysomnograph
Primary Device ID00833166000405
NIH Device Record Keyd19f3d97-0194-4871-82d0-7f45fcb13ff2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSOMNOscreen plus Accessory
Version Model NumberSEN209
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 Batchtrue
Serial Numberfalse
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
GS100833166000405 [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

On-Brand Devices [SOMNOscreen plus Accessory]

04250413400560SEN599T
04250413400430SEN635
04250413400409SEN624
04250413400379SEN603
04250413400348SEN600T
04250413400218SEN633
00833166000412SEN215
00833166000405SEN209
04250413400614SEN614
04250413400607SEN613
04250413400522SEN614O

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