| Primary Device ID | 18809315676240 |
| NIH Device Record Key | 3bd8f36d-8fdc-4b3a-9745-528a459d7241 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DTS-3000 |
| Version Model Number | DTC-C25 |
| 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 | 08809315676243 [Primary] |
| GS1 | 18809315676240 [Package] Contains: 08809315676243 Package: Box [8 Units] In Commercial Distribution |
| GS1 | 28809315676247 [Package] Contains: 08809315676243 Package: Box [20 Units] In Commercial Distribution |
| GS1 | 38809315676244 [Package] Contains: 08809315676243 Package: Box [35 Units] In Commercial Distribution |
| GS1 | 48809315676241 [Package] Contains: 08809315676243 Package: Box [25 Units] In Commercial Distribution |
| GS1 | 58809315676248 [Package] Contains: 08809315676243 Package: Box [50 Units] In Commercial Distribution |
| KCY | Tourniquet, Pneumatic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-06-24 |
| Device Publish Date | 2021-06-16 |
| 18809315676608 | AC SINGLE CUFF (DTC-SA15) 1ea |
| 18809315676592 | AC SINGLE CUFF (DTC-SA07) 1ea |
| 18809315676585 | AC SINGLE CUFF (DTC-SA06) 1ea |
| 18809315676578 | AC SINGLE CUFF (DTC-SA05) 1ea |
| 18809315676561 | AC SINGLE CUFF (DTC-SA02) 1ea |
| 18809315676554 | AC SINGLE CUFF (DTC-SA01) 1ea |
| 18809315676530 | IOP Sensor 1ea |
| 18809315676523 | GRAY MAIN HOSE 1ea |
| 18809315676516 | BLUE MAIN HOSE 1ea |
| 18809315676509 | RED MAIN HOSE 1ea |
| 18809315676493 | Cone Double Cuff (DTC-CD27) 1ea |
| 18809315676486 | Cone Double Cuff (DTC-CD26) 1ea |
| 18809315676479 | Cone Double Cuff (DTC-CD25) 1ea |
| 18809315676431 | Double Cuff(DTC-D07) 1ea |
| 18809315676370 | Double Cuff (DTC-D06) 1ea |
| 18809315676356 | Double Cuff (DTC-D05) 1ea |
| 18809315676332 | Double Cuff (DTC-D04) 1ea |
| 18809315676264 | Cone Single Cuff (DTC-C27) 1ea |
| 18809315676257 | Cone Single Cuff (DTC-C26) 1ea |
| 18809315676240 | Cone Single Cuff (DTC-C25 1ea) |
| 18809315676233 | Gray hose 1ea |
| 18809315676226 | Blue hose 1ea |
| 18809315676219 | Red hose 1ea |
| 08809315676199 | Hose set (Red 1ea, Blue 1ea, Gray 2ea) |
| 08809315676182 | Device 1ea, AC SINGLE CUFF(DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea) |
| 08809315676175 | Device 1ea, Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cuff ( |
| 18809315676165 | AC SINGLE CUFF (DTC-SA02 1ea, DTC-SA05 1ea, DTC-SA06 1ea, DTC-SA07 1ea, DTC-SA15 1ea) |
| 18809315676158 | Single Cuff (DTC-S05 1ea, DTC-S06 1ea), Cone Single Cuff (DTC-C26 1ea) Double Cuff (DTC-D04 1ea, |
| 18809315676141 | Single Cuff(DTC-S08) 1ea |
| 18809315676134 | Single Cuff(DTC-S07) 1ea |
| 18809315676127 | Single Cuff(DTC-S06) 1ea |
| 18809315676110 | Single Cuff (DTC-S05) 1ea |
| 18809315676103 | Single Cuff (DTC-S04) 1ea |
| 18809315676097 | Single Cuff (DTC-S02) 1ea |
| 08809315676076 | Device 1ea |
| 08809802643956 | Device 1ea, AC Single Cuff(DTC-SA02 1ea, DTC-SA06 1ea), Cone Single Cuff(DTC-C26 1ea), Double Cu |
| 08809802643284 | Device 1ea, Hose set (Red 1ea, Blue 1ea, Gray 2ea), IOP Sensor [One set box] |
| 08809315676304 | Device 1ea, Single Cuff(DTC-S02 1ea, DTC-S04 1ea), Cone Single Cuff(DTC-C25 1ea, DTC-C26 1ea, DT |
| 08809802644236 | Device 1ea, SILICONE BLADDER CUFF(DTC-SA1843 1ea, DTC-SA2443 1ea, DTC-SA3043 1ea, DTC-SA3443 1ea |