FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NONE
DI: B006LTE600M52
·
Model: NONE
·
NEUROVISION MEDICAL PRODUCTS, INC.
Product Codes
5
GMDN Terms
2
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- NONE
- Primary DI
- B006LTE600M52
- Version / Model
- NONE
- Company Name
- NEUROVISION MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 182057401
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 5
- Public Version Date
- 2020-12-29
- Public Version Status
- Update
- Public Device Record Key
- 3d055d11-2ea1-463f-9d59-06867800df01
- Distribution End Date
- 2020-07-01
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IKT | Electrode, Needle, Diagnostic Electromyograph | Physical Medicine | 890.1385 | 2 |
| GWF | Stimulator, Electrical, Evoked Response | Neurology | 882.1870 | 2 |
| ETN | Stimulator, Nerve | Ear, Nose, Throat | 874.1820 | 2 |
| BTR | Tube, Tracheal (W/Wo Connector) | Anesthesiology | 868.5730 | 2 |
| PDQ | Neurosurgical Nerve Locator | Ear, Nose, Throat | 874.1820 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B006LTE600M52 | HIBCC | ||||
| Unit of Use | B006LTE600M1 | HIBCC |