Olympic Brainz Monitor OBM00042

GUDID 00382830007467

Neonatal Hydrogel Sensors

NATUS MEDICAL INCORPORATED

Evoked-potential audiometer
Primary Device ID00382830007467
NIH Device Record Keyf67f7613-7363-41e1-9807-c7ecedcfd044
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlympic Brainz Monitor
Version Model NumberNeonatal Sensors
Catalog NumberOBM00042
Company DUNS962519208
Company NameNATUS MEDICAL INCORPORATED
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830007467 [Primary]

FDA Product Code

OMCReduced- Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-12-29

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