| Primary Device ID | 00850681007160 |
| NIH Device Record Key | 37a6dfbf-80d6-45b5-93a6-3afa1d157fd5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Temporal Monitoring Headframe |
| Version Model Number | NA-MOUNT2 |
| Catalog Number | NA-MOUNT2 |
| Company DUNS | 078766464 |
| Company Name | NEURAL ANALYTICS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850681007160 [Primary] |
| ITX | Transducer, Ultrasonic, Diagnostic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-19 |
| Device Publish Date | 2018-10-17 |
| 00850681007153 - 2Mhz Monitoring Transducer - 8 foot | 2018-11-19 The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity |
| 00850681007160 - Temporal Monitoring Headframe | 2018-11-19 |
| 00850681007160 - Temporal Monitoring Headframe | 2018-11-19 |
| 00850681007177 - Monitoring Headframe Foam Procedural Set | 2018-11-19 Procedural set that includes replacement foam for the Neural Analytics monitoring headframe. |
| 00850681007115 - NeuralBot Procedural Set (Single Use) | 2018-08-27 The NeuralBot procedural set contains the following single use items; probe pod covers, head cradle comfort padding, head stabil |
| 00850681007122 - NeuralBot | 2018-08-09 The NeuralBot System is a cart mounted, robotic transcranial Doppler (TCD) probe positioning accessory for the previously cleare |
| 00850681007009 - Lucid Transcranial Doppler System | 2018-07-06 The Lucid M1 System is a medical ultrasound system intended for use as an adjunct to the standard clinical practices for measuri |
| 00850681007016 - 2-MHz Transducer, Handheld | 2018-07-06 The handheld transducer is a 2 MHz single-element ultrasound transducer designed to be held by hand to perform velocity measurem |
| 00850681007023 - 2-MHz Headset/Monitoring Transducer | 2018-07-06 The monitoring transducer is a 2 MHz single-element ultrasound transducer designed for mounting on a headset to perform velocity |