| Primary Device ID | 08809315679787 |
| NIH Device Record Key | 6ba0eb1b-fefa-42fc-baba-8af98bc022ea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | RL-500 |
| Version Model Number | 1HDGM00 |
| Company DUNS | 688817949 |
| Company Name | DAESUNG MAREF CO.,LTD. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | true |
| 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 | 08809315679787 [Primary] |
| GS1 | 18809315679784 [Package] Package: [4 Units] In Commercial Distribution |
| GS1 | 28809315679781 [Package] Package: [10 Units] In Commercial Distribution |
| BXB | Exerciser, Powered |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-16 |
| Device Publish Date | 2021-03-08 |
| 08809315679787 | GLOVE 1EA |
| 18809315679814 | Hose 1ea, Com cable 1ea (1 set box) |
| 18809315679807 | Detection Hub 1ea (One poly bag) |
| 18809315679791 | PEN 1EA (One poly bag) |
| 08809315679770 | Device 1ea, CPM 1ea, GLOVE 1ea, Hose set 1ea |
| 08809315679763 | RL-500 device + CPM |