Neuroline CupNeurology Surface Electrodes

Primary DI
05707480029372
Brand
Neuroline CupNeurology Surface Electrodes
Company
Ambu A/S
Model
72610-M/10
Catalog number
72610-M/10
Device description
Cup Electrodes M Connector Lead Wire Length: 100 cm (40")
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GXYELECTRODE, CUTANEOUS

Product Code Classifications

CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707480003211PackageGS12In Commercial Distribution
05707480029372PackageGS146In Commercial Distribution
05707480021628PrimaryGS10
05707480029389Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480003211057074800032115707480003211
05707480029372057074800293725707480029372
05707480021628057074800216285707480021628
05707480029389057074800293895707480029389

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length40Inch
Length100Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+14107686464Purchase_orders@ambuUSA.com
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags

DUNS number
305682023
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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