| Primary Device ID | 05391530950121 |
| NIH Device Record Key | 0c5bcd12-935b-421a-9048-92ef3928eb11 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Neon8 KIT |
| Version Model Number | TF04K |
| Company DUNS | 985065024 |
| Company Name | INCEREB 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between -10 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05391530950107 [Primary] |
| GS1 | 05391530950121 [Package] Contains: 05391530950107 Package: Box [5 Units] In Commercial Distribution |
| GS1 | 05391530950145 [Package] Package: Shipper box [15 Units] In Commercial Distribution |
| GS1 | 05391530950299 [Package] Contains: 05391530950107 Package: Box [10 Units] In Commercial Distribution |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-04-01 |
| Device Publish Date | 2022-03-24 |
| 05391530950367 - N10 NeuroBell | 2026-02-24 EEG electrode array, 10 electrodes, NeuroBell branding |
| 05391530950091 - Neon 12 KIT | 2022-04-01 Kit version of neon12, packaged without electrode paste or skin prep gel |
| 05391530950121 - Neon8 KIT | 2022-04-01Neon8 KIT version, packaged without electrode paste or skin prep gel |
| 05391530950121 - Neon8 KIT | 2022-04-01 Neon8 KIT version, packaged without electrode paste or skin prep gel |
| 05391530950084 - neon8 | 2022-01-24 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only. This |
| 05391530950022 - neon12 | 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 12 electrodes. The device is single use only |
| 05391530950053 - neon8 | 2018-07-06 EEG electrode array sized for use with neonatal infants. The array has qty 8 electrodes. The device is single use only |