FDA.reportPublic FDA data

NONE

Primary DI
B006NVFKITNP52
Brand
NONE
Company
Neurovision Medical Products, Inc.
Model
NONE
Catalog number
DSPNVFKITNP-5
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
ETNStimulator, Nerve
GWFStimulator, Electrical, Evoked Response
IKTElectrode, Needle, Diagnostic Electromyograph

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2
IKTElectrode, Needle, Diagnostic ElectromyographPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
NVFKITNP5PackageHIBCC5In Commercial Distribution
B006NVFKITNP52PrimaryHIBCC0
00810155861087SecondaryGS10
B006NVFKITNP1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155861087008101558610878101558610870810155861087

GMDN Terms#

Term, Definition table
TermDefinition
Electromyographic endotracheal tubeA sterile hollow cylinder intended to be inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. The device also has a conducting strip in its distal portion to function as an electrode to monitor the electromyographic (EMG) activity of the laryngeal and vocal cord musculature. The device has a ventilator tube connector, radiopaque strip, and is connected to an appropriate EMG measuring/recording device. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
182057401
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810155862589NONENONEDSPRLNKIT-LT-52025-12-19
00810155862602NONENONEDSPRLNKIT-MT-52025-12-19
00810155862626NONENONEDSPRLNKIT-ST-52025-12-19
00810155862640NONENONEDSPRLNKIT-L-52025-12-19
00810155862664NONE NONEDSPRLNKIT-M-52025-12-19
00810155862688NONENONEDSPRLNKIT-S-52025-12-19
B006NVHS102NONENONEDSPRLNKIT-M-52025-12-18
B006NVHS1021NONENONEDSPRLNKIT-M-52025-12-18
B006IDKATF714B52ScorpionN/ADSPI-DK-ATF714B-52021-11-17
B006IDKMF512B52ScorpionN/ADSPI-DK-MF512B-52021-11-17
B006IDKWSF51252ScorpionN/ADSPI-DK-WSF512-52023-09-01
B006LTE7003PL52CobraN/ADSPLTE7003PL-52020-08-12
B006LTE7003PLD52Cobra®N/ADSPLTE7003PLD-52023-03-20
B006LTE7003PLT52CobraN/ADSPLTE7003PLT-52020-08-12
B006LTE7003PM52CobraN/ADSPLTE7003PM-52020-08-12
B006LTE7003PMD52Cobra®N/ADSPLTE7003PMD-52023-04-06
B006LTE7003PMT52CobraN/ADSPLTE7003PMT-52020-08-12
B006IDKMCF512B52NONENONEDSPI-DK-MCF512B-52016-09-24
B006IDKSHEMM52NONENONEDSPI-DK-SHEM-M-52016-09-24
B006IJRF714B0NONENONEREUI-JRF714B2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08056446900338NeMus 2 600EB NEURO SPAGWF2025-05-26
08056446900345NeMus 2 700EB NEURO SPAGWF2025-05-26
08056446900352NeMus 2 +EB NEURO SPAGWF2025-05-26
08056446901106NExT-DOCKINGEB NEURO SPAGWF2025-05-22
08056446901113NExT-PADEB NEURO SPAGWF2025-05-22
08056446901120NExT-AMP-ADVANCEDEB NEURO SPAGWF2025-05-22
08056446901137NExT-HSEB NEURO SPAGWF2025-05-22
08056446901168NExT-AMPEB NEURO SPAGWF2025-05-22
08056446901199NExT-ASEB NEURO SPAGWF2025-05-22
08056446901205NExT StationEB NEURO SPAGWF2025-05-22
08056446901090NExT Station AdvancedEB NEURO SPAGWF2025-05-19
08718375866061Neurosign V4Technomed Engineering B.V.ETN2022-07-04
08056446900642Galileo NT Line SoftwareEB NEURO SPAGWF2020-05-25
08718375861707Technomed EuropeTechnomed Engineering B.V.IKT2019-11-21
08056446900208NeMus SYSTEMEB NEURO SPAGWF2019-05-24
08056446900215NeMus PC PERIPHERALEB NEURO SPAGWF2019-05-24
08056446900222NeMus 1EB NEURO SPAGWF2019-05-24
08056446900239NeMus 1EB NEURO SPAGWF2019-05-24
08056446900246Power-LAN Connection BoxEB NEURO SPAGWF2019-05-24
08056446900260R-KEY (Dedicated Keyboard)EB NEURO SPAGWF2019-05-24
08056446900253Power-LAN Connection Box USBEB NEURO SPAGWF2019-04-10
08056446900369NeMus 2EB NEURO SPAGWF2019-04-10
08056446900376NeMus 2EB NEURO SPAGWF2019-04-10
08033315122299BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122312BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122336BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122350BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122374BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122398BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04
08033315122411BIONENBIONEN SAS DI BARBARA NENCIONI & C.IKT2018-09-04