Primary Device ID | 18809315676592 |
NIH Device Record Key | 48036fbd-8da3-445a-a672-dfb127af0831 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DTS-3000 |
Version Model Number | DTC-SA07 |
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 | 08809315676595 [Primary] |
GS1 | 18809315676592 [Package] Contains: 08809315676595 Package: Box [4 Units] In Commercial Distribution |
GS1 | 28809315676599 [Package] Contains: 08809315676595 Package: Box [7 Units] In Commercial Distribution |
GS1 | 38809315676596 [Package] Contains: 08809315676595 Package: Box [17 Units] In Commercial Distribution |
GS1 | 48809315676593 [Package] Contains: 08809315676595 Package: Box [12 Units] In Commercial Distribution |
GS1 | 58809315676590 [Package] Contains: 08809315676595 Package: Box [21 Units] In Commercial Distribution |
GS1 | 68809315676597 [Package] Contains: 08809315676595 Package: Box [36 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 |