FDA.reportPublic FDA data

Cumulus Functional Neurophysiology Platform

Primary DI
05061027610011
Brand
Cumulus Functional Neurophysiology Platform
Company
CUMULUS NEUROSCIENCE LIMITED
Model
CN-T5H
Catalog number
CN-T5H
Device description
Cumulus EEG Headset and Mobile Application
Published
2024-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GWQFull-Montage Standard Electroencephalograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GWQFull-Montage Standard ElectroencephalographNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221963000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221963000Cumulus Functional Neurophysiology PlatformCumulus Neuroscience Limited2023-04-27GWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05061027610011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05061027610011050610276100115061027610011

GMDN Terms#

Term, Definition table
TermDefinition
Electroencephalographic electrode cap, reusableAn array of analytical scalp electrodes preconfigured within a head-worn device designed for the rapid placement and appropriate positioning of the scalp electrodes during electroencephalography (EEG). It typically consists of a cap with integrated (and often removable) scalp electrodes, and shielded lead wires that terminate into a connector that mates with a separate cable. The device eliminates the need to glue or paste individual electrodes to the patient’s scalp. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442892646600info@cumulusneuro.com

Regulatory Flags#

DUNS number
220568006
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Company table
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00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyGWQ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyGWQ2023-04-19
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09342451002112SiestaCompumedics Usa, Inc.GWQ2020-12-16
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