Primary Device ID | 18809315679807 |
NIH Device Record Key | d69e1766-4ea6-44c2-916e-2e352e358456 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | RL-500 |
Version Model Number | RL5A210 |
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 | 08809315679800 [Primary] |
GS1 | 18809315679807 [Package] Contains: 08809315679800 Package: Box [5 Units] In Commercial Distribution |
GS1 | 28809315679804 [Package] Contains: 08809315679800 Package: Box [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 | 2021-06-22 |
Device Publish Date | 2021-06-14 |
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 |