FDA.report

Neuroline Cup

Primary DI
05707480146628
Brand
Neuroline Cup
Company
Ambu A/S
Model
72620-M/23
Catalog number
72620-M/23
Device description
Ambu Neuroline Cup, 200 cm leadwire, Colour Kit of 23 pcs .
Published
2021-06-01
Public version status
New
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
05707480146628PackageGS12In Commercial Distribution
05707480146635PackageGS120In Commercial Distribution
05707480146642PrimaryGS10
05707480153961Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707480146628057074801466285707480146628
05707480146635057074801466355707480146635
05707480146642057074801466425707480146642
05707480153961057074801539615707480153961

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
Length200Centimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius25 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
23
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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05707480025435AuraOnce321500000U321500000U2022-12-08
05707480025527AuraOnce321600000U321600000U2022-12-08

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