| Primary Device ID | 00813153025000 |
| NIH Device Record Key | 5d719cde-75bf-4414-8181-bafaeac47b9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Walrus by CODAN |
| Version Model Number | A 817-W |
| 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 | 00813153025000 [Package] Contains: 10813153025007 Package: Multivac packaging [1 Units] In Commercial Distribution |
| GS1 | 10813153025007 [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 | 2025-06-09 |
| Device Publish Date | 2025-05-30 |
| 00813153027882 - LABEL PRODUCT -CODAN | 2025-09-04 Extension Set with 1.2-micron Filter |
| 00813153027936 - LABEL PRODUCT -CODAN | 2025-09-04 Blood Transfer Set |
| 00813153027967 - Kabi Access Infusion Sets | 2025-09-04 Stopcock 4-way stopcock with rotating Luer-lock |
| 00813153027981 - Kabi Access Infusion Sets | 2025-09-04 Short Extension Set T-Connector |
| 00813153028001 - Kabi Access Infusion Sets | 2025-09-04 Manifold 2 Port 4-way stopcocks and rotating male Luer-lock |
| 00813153028018 - Kabi Access Infusion Sets | 2025-09-04 Manifold 4 Port 4-way Stopcocks on a manifold plate |
| 00813153028025 - LABEL PRODUCT -CODAN | 2025-09-04 Vented Transfer Set with Female Luer-lock |
| 00813153027929 - LABEL PRODUCT -CODAN | 2025-09-04 Neonatal Blood Administration Set with Filter & 30cc Syringe |