| Primary Device ID | 09342451001061 |
| NIH Device Record Key | 5a9187e2-2988-4bbd-8397-bab2a8bf81f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Compumedics Neuvo |
| Version Model Number | Neuvo Headbox (Amplifier) 64 Ch - Wall Column Kit |
| Catalog Number | 9022-0008-01 |
| Company DUNS | 753750967 |
| Company Name | COMPUMEDICS LIMITED |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 50 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09342451001061 [Primary] |
| GWQ | Full-Montage Standard Electroencephalograph |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-04-27 |
| Device Publish Date | 2016-10-27 |
| 09342451001207 | Cable Assembly, LTM to Amplifier , NEMO - 10m |
| 09342451001184 | Dual Headbox Bracket, Neuvo System Mounting Kits (AC376) |
| 09342451001177 | Neuvo Headbox 128Ch - Wall Column Kit |
| 09342451001160 | Cable - Neuvo Control Unit, 2 meters |
| 09342451001153 | LTM Harness Cover |
| 09342451001146 | Bracket - System Unit Neuvo System Mounting Kits |
| 09342451001139 | Bracket Event Button - Neuvo Base Trolley and Wall Column |
| 09342451001122 | Bracket - LTM Headbox - Neuvo System Mounting Kits |
| 09342451001115 | Bracket - Headbox, Neuvo System Mounting Kits |
| 09342451001108 | Bracket - Headbox Mount |
| 09342451001092 | Neuvo Headbox Assembly |
| 09342451001085 | Neuvo System Unit Assembly |
| 09342451001078 | LTM Module Assembly- Neuvo |
| 09342451001061 | Neuvo Headbox (Amplifier) 64 Ch - Wall Column Kit |
| 09342451001054 | Neuvo System Unit Assembly - no HDD |
| 09342451001047 | LTM Module - Neuvo |
| 09342451001030 | Neuvo Event Button V2 |
| 09342451001023 | Neuvo Wall Mount Assembly |
| 09342451001016 | System-Neuvo Wall Mnt 64 Ch LTM |