Olympic CFM

Primary DI
00382830053839
Brand
Olympic CFM
Company
NATUS MEDICAL INCORPORATED
Model
Electrode Hydrogel
Catalog number
200249-507, 62050, 62051
Device description
Neonatal EEG Hydrogel sensor
Published
2017-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OMAAmplitude-Integrated Electroencephalograph
OMCReduced- Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OMAAmplitude-Integrated ElectroencephalographNeurology2
OMCReduced- Montage Standard ElectroencephalographNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382830004053PackageGS1100In Commercial Distribution
00382830053839PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382830004053003828300040533828300040530382830004053
00382830053839003828300538393828300538390382830053839

GMDN Terms#

Term, Definition table
TermDefinition
Analytical scalp electrode, single-useA noninvasive electrical conductor designed to be attached to the scalp surface of a patient to transmit changes in the electrical potential of various areas of the brain for recording/monitoring by a connected parent device [i.e., an electroencephalograph (EEG), sleep, or evoked potential recording device]. It typically consists of a small cup/disk with a conductive surface (e.g., tin, gold, conductive plastic) and a length of insulated connecting wire; it may be available as a set of multiple electrodes (e.g., EEG electrodes) however it is not a preconfigured EEG cap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Contacts#

Phone, Email table
PhoneEmail
1-800-303-0306Technical_service@natus.com

Regulatory Flags#

DUNS number
962519208
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

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