Olympic CFM 200249-507, 62050, 62051

GUDID 00382830004053

Neonatal EEG Hydrogel sensor

NATUS MEDICAL INCORPORATED

Analytical scalp electrode, single-use Analytical scalp electrode, single-use
Primary Device ID00382830004053
NIH Device Record Keyb751f9b8-407e-4c16-8091-aedba87725a4
Commercial Distribution StatusIn Commercial Distribution
Brand NameOlympic CFM
Version Model NumberElectrode Hydrogel
Catalog Number200249-507, 62050, 62051
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 Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-303-0306
EmailTechnical_service@natus.com
Phone1-800-303-0306
EmailTechnical_service@natus.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100382830004053 [Package]
Contains: 00382830053839
Package: [100 Units]
In Commercial Distribution
GS100382830053839 [Primary]

FDA Product Code

OMAAmplitude-Integrated 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 Date2017-03-31

Devices Manufactured by NATUS MEDICAL INCORPORATED

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10382830062289 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062296 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062302 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062319 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062326 - Natus2023-05-12 CRANIAL ACCESS KIT
10382830062333 - Natus2023-05-12 CRANIAL ACCESS KIT
10381780039310 - CAMINO®2020-05-06 Intracranial Pressure and Temperature Monitor

Trademark Results [Olympic CFM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OLYMPIC CFM
OLYMPIC CFM
77760382 not registered Dead/Abandoned
Natus Medical Incorporated
2009-06-16

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