| Primary Device ID | 00813153027929 |
| NIH Device Record Key | 747d850e-81ee-4fd5-ab54-b306a0069fef |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LABEL PRODUCT -CODAN |
| Version Model Number | B685 |
| 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 | 00813153027929 [Package] Contains: 20813153027923 Package: Chevron Pouch [1 Units] In Commercial Distribution |
| GS1 | 20813153027923 [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 |
| 00813153022672 | Extension Set with Needle Valve & Needlefree T-connector |
| 00813153022344 | Extension Set with Spin-Lock |
| 10813153028039 | One Way Stopcock with Rotating Male Luer lock |
| 00813153022955 | Bifurcated Blood Set with Spin-lock |
| 00813153021613 | IV Extension Set with Stopcock, Injection Sites, & T-connector |
| 00813153028094 | Microbore Extension Set |
| 00813153028087 | IV Administration Set |
| 00813153028049 | Trifurcated Extension Set with 0.2-micron Filter |
| 00813153027950 | Regular Bore Extension Set w/ 5 Neutral Valves |
| 00813153027943 | Minibore Extension Set w/ 5 Neutral Valves |
| 00813153027912 | 3-Way Stopcock |
| 00813153027875 | Extension Set with 0.2-micron Filter |
| 00813153027929 | Neonatal Blood Administration Set with Filter & 30cc Syringe |
| 00813153028025 | Vented Transfer Set with Female Luer-lock |
| 00813153027936 | Blood Transfer Set |
| 00813153027882 | Extension Set with 1.2-micron Filter |