| Primary Device ID | B525ST160 |
| NIH Device Record Key | fd809775-9028-4e0a-92af-5892d5d5397d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XL Flanel Blanket |
| Version Model Number | ST-16 |
| Company DUNS | 240536946 |
| Company Name | Octostop Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B525ST160 [Primary] |
| KXH | Cradle, patient, radiologic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-03-11 |
| Device Publish Date | 2017-11-16 |
| B525BO020 - Standard Board | 2019-03-11 |
| B525BO030 - Large Board | 2019-03-11 |
| B525CO010 - Large U Head Cushions | 2019-03-11 |
| B525CO020 - Small U Head Cushions | 2019-03-11 |
| B525CO030 - L Head and Arm Cushions | 2019-03-11 |
| B525OC010 - Octogones | 2019-03-11 |
| B525OC020 - Vertical Support | 2019-03-11 |
| B525PA030 - Octopaque no Accessories | 2019-03-11 |