| Primary Device ID | 50618029980026 |
| NIH Device Record Key | d869a7be-d599-4c47-a970-d6ab3d3043c4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Self Oral Care Kit |
| Version Model Number | 700-083 |
| Catalog Number | 700-083 |
| Company DUNS | 054326178 |
| Company Name | SAGE PRODUCTS, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00618029980021 [Primary] |
| GS1 | 50618029980026 [Package] Contains: 00618029980021 Package: case [24 Units] In Commercial Distribution |
| JOL | CATHETER AND TIP, SUCTION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-01-10 |
| Device Publish Date | 2018-12-10 |
| 50618029980026 | Patient Personal Hygiene Kit |
| 50618029980033 | Patient Personal Hygiene Kit |