FDA.reportPublic FDA data

Cobra

Primary DI
B006LTE7003PLT52
Brand
Cobra
Company
Neurovision Medical Products, Inc.
Model
N/A
Catalog number
DSPLTE7003PLT-5
Published
2020-08-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
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
B006LTE7003PLT52PrimaryHIBCC0
00810155860806SecondaryGS10
B006LTE7003PLT1Unit of UseHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810155860806008101558608068101558608060810155860806

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.

Regulatory Flags#

DUNS number
182057401
Device count
5
Kit
true
Lot or batch
true
Expiration date on label
true
No 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
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
10197344104659MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104666MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104673MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104680MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104697MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104703MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104710MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104727MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104734MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104741MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104758MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104765MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104772MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104789MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104796MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104802MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104819MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104826MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104833MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104840MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104857MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104864MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104871MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104888MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104895MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
10197344104901MEDLINEMEDLINE INDUSTRIES, INC.BTR2026-01-12
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