FDA.reportPublic FDA data

Neuroline 700Neurology Surface Electrodes

Primary DI
05707480022595
Brand
Neuroline 700Neurology Surface Electrodes
Company
Ambu A/S
Model
70015-K/12
Catalog number
70015-K/12
Device description
Neurology surface electrodes
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYELECTRODE, CUTANEOUS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05707480000470PackageGS18In Commercial Distribution
05707480022465PackageGS110In Commercial Distribution
05707480022595PrimaryGS10
05707480023516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05707480000470057074800004705707480000470
05707480022465057074800224655707480022465
05707480022595057074800225955707480022595
05707480023516057074800235165707480023516

GMDN Terms#

Term, Definition table
TermDefinition
Analytical non-scalp cutaneous electrodeAn electrical conductor designed to be attached to the skin surface of a patient outside of the hair line (i.e., non-scalp) to conduct electrical signals to/from a parent device for electrophysiological recording/monitoring [e.g., electromyography (EMG), evoked potentials (EP), nerve conduction study (NCS), bioelectrical impedance]; it is not primarily intended for diagnostic electrocardiography (ECG) or electroencephalography (EEG). It typically consists of a small rectangular tab or cup/disk with a conductive surface, which may include a lead wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length150Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(410)768-6464Purchase_orders@ambuUSA.com

Regulatory Flags#

DUNS number
305682023
Device count
12
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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05707480167593Ambu® Neuroline Monopolar74225-36/4074225-36/402026-09-05
05707480167609Ambu® Neuroline Monopolar74238-36/4074238-36/402026-09-05
05707480167630Ambu® Neuroline Monopolar74325-36/4074325-36/402026-09-05
05707480167661Ambu® Neuroline Monopolar74338-36/4074338-36/402026-09-05
05707480145287aScope™ Duodeno4820010004820010002020-08-10
05707480157402aScope™ Duodeno482001000/4482001000/42022-04-19
05707480136032Isiris™ MonitorMN0001MN00012018-07-30
05707480156306aScope™ 5 Broncho HD 5.0/2.2621001000US621001000US2022-08-19
05707480156337aScope™ 5 Broncho HD 5.6/2.8622001000US622001000US2022-08-19
05707480157259aScope™ 5 Broncho 4.2/2.2620001000US620001000US2023-08-25
05707480157280aScope™ 5 Broncho 2.7/1.2624001000US624001000US2023-08-25
05060038511034Ambu® WhiteSensor 4055440554405542026-08-07
05707480024650Ambu® Mini Perfit ACE™0002811060002811062022-12-08
05707480024674Ambu® Immobilization Kit, with0002811610002811612022-12-08
05707480026197BlueSensor NEOXECG ElectrodesNEOX-60-K/US/3NEOX-60-K/US/32016-09-21
05707480024513Ambu® Perfit Collar™0002642010002642012022-12-08
05707480024520Ambu® Perfit Collar™0002642020002642022022-12-08
05707480024537Ambu® Perfit Collar™0002642030002642032022-12-08
05707480024544Ambu® Perfit Collar™0002642040002642042022-12-08

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Primary DI, Brand, Company table
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