MUX Interfaced Measurement Adapter

GUDID 04250413400553

SOMNOmedics GmbH

Patient monitoring system module, multifunction
Primary Device ID04250413400553
NIH Device Record Key9dc3b159-dcfa-4fdd-964a-63a0835ed5a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameMUX Interfaced Measurement Adapter
Version Model NumberSEN658
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
GS104250413400553 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-22
Device Publish Date2019-04-12

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