FDA.report

NONE

Primary DI
00810155862664
Brand
NONE
Company
Neurovision Medical Products, Inc.
Model
NONE
Catalog number
DSPRLNKIT-M-5
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
ETNStimulator, Nerve

Product Code Classifications

CodeDeviceSpecialtyClass
ETNStimulator, NerveEar, Nose, Throat2

Premarket Submissions

SubmissionSupplement
K110989000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810155862664PrimaryGS10
00810155862657Unit of UseGS10

GMDN Terms

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
Ethylene Oxide

Regulatory Flags

DUNS number
182057401
Device count
5
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
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810155862589NONENONEDSPRLNKIT-LT-52025-12-19
00810155862602NONENONEDSPRLNKIT-MT-52025-12-19
00810155862626NONENONEDSPRLNKIT-ST-52025-12-19
00810155862640NONENONEDSPRLNKIT-L-52025-12-19
00810155862688NONENONEDSPRLNKIT-S-52025-12-19
B006NVHS1021NONENONEDSPRLNKIT-M-52025-12-18
B066HGELS1NONENONE2025-02-12
B006IJCBFB60NONENONE2025-02-12
B006NVPS2Nerveäna+®NONE2025-02-11
B006NVPMK1Nerveäna+®NONE2024-02-01
B006NVPSTST2Nerveäna+®NONE2024-02-01
B006NVPT1Nerveäna+®NONE2024-02-01
B006NVPTKITC3P6WSF5Nerveana+®N/A2024-02-01
NVPTKITC3P7WSF5Nerveana+®N/A2024-02-01
NVPTKITC3P8WSF5Nerveana+®N/A2024-02-01
NVPTKITDCLD5Nerveana+®N/A2024-02-01
NVPTKITDCLWF5Nerveäna+®NONE2024-02-01
NVPTKITDCSD5Nerveana+®N/A2024-02-01
NVPTKITDCSWF5Nerveäna+®NONE2024-02-01
B006NVPUSB1Nerveäna+®NONE2024-02-01

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