| Primary Device ID | 10816203022193 |
| NIH Device Record Key | 0f3dfe70-5d1f-4e3c-bade-ef48c7b679c2 |
| Commercial Distribution Discontinuation | 2024-04-22 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | TubeSet Adapter |
| Version Model Number | 4S-M40 |
| Company DUNS | 625272232 |
| Company Name | ORIGEN BIOMEDICAL, INC. |
| 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 | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com | |
| Phone | 512-474-7278 |
| regulatory@origen.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203022193 [Primary] |
| GS1 | 20816203022190 [Package] Package: Case [12 Units] Discontinued: 2024-04-22 Not in Commercial Distribution |
| KJG | Tube, Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2024-04-23 |
| Device Publish Date | 2016-09-23 |
| 10816203022339 | One spike to one female luer with 12cm SCD Tubing, case of 50 |
| 10816203020601 | Two male luers to one male luer with 17cm of DMSO resistant tubing |
| 10816203020595 | Two male luers to one female luer with 17cm of DMSO resistant tubing |
| 10816203020014 | 4x12cm SCD tubing tube set |
| 10816203022193 | Adapter tube set, 4 bag spikes x 1 Male luer, 40cm |