| Primary Device ID | 00813153026502 |
| NIH Device Record Key | c583bab5-38f9-4312-a2ba-e0d145455348 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REM |
| Version Model Number | BC 2148 |
| 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 | false |
| 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 | 00813153026502 [Package] Contains: 10813153026509 Package: [1 Units] In Commercial Distribution |
| GS1 | 10813153026509 [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 | 2022-01-10 |
| Device Publish Date | 2021-12-31 |
| 00813153028124 - FRESENIUS KABI | 2026-02-13 Extension Set |
| 00813153028131 - FRESENIUS KABI | 2026-02-13 Filter Extension Set - Non PVC Fluid Path |
| 00813153028148 - FRESENIUS KABI | 2026-02-13 Filter Extension Set - Non PVC Fluid Path |
| 00813153028155 - FRESENIUS KABI | 2026-02-13 Filter Extension Set - Non PVC Fluid Path |
| 00813153028179 - Codan | 2026-01-29 Trifurcated Extension Set |
| 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 |