FDA.reportPublic FDA data

NONE

Primary DI
00810155862626
Brand
NONE
Company
Neurovision Medical Products, Inc.
Model
NONE
Catalog number
DSPRLNKIT-ST-5
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTRTube, Tracheal (W/Wo Connector)
ETNStimulator, Nerve
GWFStimulator, Electrical, Evoked Response

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTRTube, Tracheal (W/Wo Connector)Anesthesiology2
ETNStimulator, NerveEar, Nose, Throat2
GWFStimulator, Electrical, Evoked ResponseNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110989000NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODENeurovision Medical Products, Inc.2011-11-03ETN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810155862626PrimaryGS10
00810155862619Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155862626008101558626268101558626260810155862626
00810155862619008101558626198101558626190810155862619

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
Ethylene Oxide

Regulatory Flags#

DUNS number
182057401
Device count
5
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810155862589NONENONEDSPRLNKIT-LT-52025-12-19
00810155862602NONENONEDSPRLNKIT-MT-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
B006IJRF714BL0NONENONEREUI-JRF714B-L2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08681823002772Bioscope Neuromonitor DeviceBIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETIETN2026-06-03
00810003750495KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750501KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750518KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750525KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750532KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750549KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750556KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750563KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750570KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750587KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750594KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750600KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750617KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750624KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750631KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750648KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750655KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750662KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750679KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750686KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750693KENTRONKENTRON HEALTHCARE, INC.BTR2026-06-01
00810003750396KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750402KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750419KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750426KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750433KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750440KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750457KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27
00810003750464KENTRONKENTRON HEALTHCARE, INC.BTR2026-05-27