| Primary Device ID | 08806369452007 |
| NIH Device Record Key | af05d39a-f56c-4b9b-8aa8-fe7feebc9fa4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BAROVAC® Evacuator Closed Wound Drainage System(SS) |
| Version Model Number | SS100M(3.2) |
| Company DUNS | 687784405 |
| Company Name | Sewoon Medical 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08806369452007 [Primary] |
| GCY | Apparatus, Suction, Single Patient Use, Portable, Nonpowered |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-04 |
| Device Publish Date | 2023-07-27 |
| 08806369498685 | SS200L4+(4.8) |
| 08806369453646 | SS400XL+ 24fr |
| 08806369453622 | SS250XL+ 20fr |
| 08806369453585 | SS250JP(4.8) |
| 08806369453561 | SS250L+(4.8) |
| 08806369453547 | SS250L(4.8) |
| 08806369453509 | SS250M(3.2) |
| 08806369453103 | SS200L3+(4.8) |
| 08806369453080 | SS200JP(4.8) |
| 08806369453066 | SS200L+(4.8) |
| 08806369453042 | SS200L(4.8) |
| 08806369453028 | SS200M+(3.2) |
| 08806369453004 | SS200M(3.2) |
| 08806369452649 | SS150XL+24fr |
| 08806369452625 | SS150XL+20fr |
| 08806369452601 | SS150L+16fr |
| 08806369452588 | SS150JP(4.8) |
| 08806369452564 | SS150L+(4.8) |
| 08806369452526 | SS150M+(3.2) |
| 08806369452120 | SS100M2(3.2) |
| 08806369452106 | SS100JP(4.8) |
| 08806369452083 | SS100LD(4.8) |
| 08806369452069 | SS100L+(4.8) |
| 08806369452045 | SS100L(4.8) |
| 08806369452021 | SS100M+(3.2) |
| 08806369452007 | SS100M(3.2) |
| 08806369427494 | PS400L(4.8)S |
| 08806369427456 | SS200L+(4.8)S |
| 08806369427418 | SS200L(4.8)S |
| 08806369427371 | SS200M(3.2)S |
| 08806369427333 | SS100M(3.2)S |
| 08806369400244 | SS200L2+(4.8) |
| 08806369400220 | SS200M2+(3.2) |