| Primary Device ID | 00646311551864 |
| NIH Device Record Key | 716d1933-7923-4a5f-bd9a-5ceab1bd9faa |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | K-SHIELD PORT ACCESS INFUSION SET with Antineedle Stick Protector |
| Version Model Number | PS02Y00 |
| Company DUNS | 699595406 |
| Company Name | KAWASUMI LABORATORIES, INCORPORATED |
| 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 | 00646311551864 [Primary] |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-10-23 |
| Device Publish Date | 2016-09-20 |
| 00646311551987 | PS04001 |
| 00646311551963 | PS02N21 |
| 00646311551956 | PS02N20 |
| 00646311551949 | PS02N01 |
| 00646311551932 | PS02N00 |
| 00646311551925 | PS02N91 |
| 00646311551918 | PS02N90 |
| 00646311551901 | PS01N90 |
| 00646311551895 | PS02Y21 |
| 00646311551888 | PS02Y20 |
| 00646311551871 | PS02Y01 |
| 00646311551864 | PS02Y00 |
| 00646311551857 | PS02Y91 |
| 00646311551840 | PS02Y90 |
| 00646311551833 | PS01Y21 |
| 00646311551826 | PS01Y20 |
| 00646311551819 | PS01Y01 |
| 00646311551802 | PS01Y00 |
| 00646311551796 | PS01Y91 |
| 00646311551789 | PS01Y90 |
| 00646311551710 | PS04021 |
| 00646311551703 | PS04020 |
| 00646311551680 | PS04000 |
| 00646311551673 | PS04091 |
| 00646311551666 | PS04090 |
| 00646311551475 | PS03090 |
| 00646311551345 | PS01N21 |
| 00646311551338 | PS03091 |
| 00646311551321 | PS03021 |
| 00646311551314 | PS03001 |
| 00646311551307 | PS03020 |
| 00646311551291 | PS03000 |
| 00646311551284 | PS01N01 |
| 00646311551277 | PS01N91 |
| 00646311551260 | PS01N20 |
| 00646311551253 | PS01N00 |