| Primary Device ID | 00850154007000 |
| NIH Device Record Key | d5b38ba6-e369-42d3-b124-b1e1185da50a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CERVELLO 32 |
| Version Model Number | 7511 |
| Catalog Number | 7511 |
| Company DUNS | 069799474 |
| Company Name | BLACKROCK NEUROMED, LLC |
| 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 |
| Phone | 801-994-5662 |
| support@blackrockneuromed.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850154007000 [Primary] |
| GWK | Conditioner, Signal, Physiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-07-15 |
| 00850154007086 - CERVELLO SOFTWARE | 2019-07-12 Cervello Software for use with Blackrock Neuromed systems, version 1.04 and all sub releases. |
| 00850154007079 - MORPHEUS | 2018-07-06 Micromed MORPHEUS Amplifer for HOME LTM. |
| 00850154007000 - CERVELLO 32 | 2018-03-29Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model |
| 00850154007000 - CERVELLO 32 | 2018-03-29 Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model |
| 00850154007017 - CERVELLO 64 | 2018-03-29 Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - Bluetooth Model |
| 00850154007024 - CERVELLO 32 W | 2018-03-29 Cervello 32 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model |
| 00850154007031 - CERVELLO 64 W | 2018-03-29 Cervello 64 LTM / Ambulatory Headbox, needs Jack Box - WiFi Model |
| 00850154007048 - JB CERVELLO 32 | 2018-03-29 JackBox with 32 Common Reference Inputs, 21 arranged as Head Shape, 8 to be switched to Bipolar, to be used with CERVELLO 32 Ser |
| 00850154007055 - JB CERVELLO 64 | 2018-03-29 JackBox with 64 Common Reference Inputs, with 6 of them to be switched to Bipolar, to be used with CERVELLO 64 Series Headboxes |