| Primary Device ID | 00813153028018 |
| NIH Device Record Key | c5cb1577-691a-4c27-9a6c-95c8b15e8e1e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Kabi Access Infusion Sets |
| Version Model Number | FK70111K |
| Company DUNS | 058027475 |
| Company Name | Codan US Corporation |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00813153028018 [Package] Contains: 10813153028015 Package: Multivac packaging [1 Units] In Commercial Distribution |
| GS1 | 10813153028015 [Primary] |
| FPA | Set, Administration, Intravascular |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-09-04 |
| Device Publish Date | 2025-08-27 |
| 00813153028018 | Manifold 4 Port 4-way Stopcocks on a manifold plate |
| 00813153028001 | Manifold 2 Port 4-way stopcocks and rotating male Luer-lock |
| 00813153027981 | Short Extension Set T-Connector |
| 00813153027967 | Stopcock 4-way stopcock with rotating Luer-lock |