| Primary Device ID | 00864302000317 |
| NIH Device Record Key | b86f3f4b-b027-4f85-bd15-2a84e57a1130 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ebb Insomnia Therapy |
| Version Model Number | VA Kit |
| Company DUNS | 877328174 |
| Company Name | CEREVE 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 | 00864302000317 [Primary] |
| PLU | Thermal System For Insomnia |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-06-10 |
| Device Publish Date | 2019-05-31 |
| 00864302000355 | Ebb Insomnia Therapy headgear assembly without the tube sleeve for clinical demonstrations to al |
| 00864302000348 | Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t |
| 00864302000331 | Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t |
| 00864302000324 | Replenish kit including replacement fluid cartridge and headgear with tubing for the Ebb Insomni |
| 00864302000300 | Ebb Insomnia Theraypy is a wearable therapy system with a bedside controller, forehead pad and t |
| 00864302000317 | Packages an Ebb Insomnia Therapy Starter kit with a replenish kit, 2 replacement cartridges and |