DEVICE: Nerveana+® (B006NVPTKITC3P6WSF52)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61070 | Electromyographic endotracheal tube |
A 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.
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Active | false |
11441 | Electromyographic needle electrode, single-use |
A sterile electrical conducting device designed to be inserted percutaneously into muscle or nerve tissue to detect bioelectrical signal activity. It is a needle-like device (a needle electrode with an electrical connector at the proximal end) that is connected to an electromyograph (EMG) with a dedicated cable/lead. The EMG records the electrical signals and converts them into a readable graph format; it is not primarily intended for nerve stimulation. This is a single-use device.
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Active | false |
61089 | Nerve-locating system probe, single-use |
A hand-held surgical instrument intended to function as an electrical conductor to locate a nerve during open surgery, and for diagnostic purposes [electromyography (EMG), cortical mapping], by delivering controlled electrical impulses to a specific body site for the measurement of a neural response. It may be in the form of a needle probe or surgical forceps which is attached to an electrical pulse generator. This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ETN | Stimulator, Nerve |
BTR | Tube, Tracheal (W/Wo Connector) |
GWF | Stimulator, Electrical, Evoked Response |
IKT | Electrode, Needle, Diagnostic Electromyograph |
GXZ | Electrode, Needle |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
11547d85-f2af-4779-8a96-13a89c5b324f
June 16, 2025
2
February 01, 2024
June 16, 2025
2
February 01, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
NVPTKITC3P6WSF5 | 5 | B006NVPTKITC3P6WSF5 | In Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B006NVPTKITC3P6WSF5
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined