| Primary Device ID | 20816203022435 |
| NIH Device Record Key | fa70dca5-65a3-43d4-a05b-add740c41554 |
| Commercial Distribution Discontinuation | 2024-12-11 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | Accessory Set |
| Version Model Number | 30-P-6M |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203022438 [Primary] |
| GS1 | 20816203022435 [Package] Contains: 10816203022438 Package: Case [12 Units] Discontinued: 2024-12-11 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 | 2024-12-12 |
| Device Publish Date | 2016-09-23 |
| 20816203023265 | Two spikes to nine male luers with 140cm SCD tubing and pinch clamps |
| 20816203023197 | One female luer to 9 male luers, 45cm PVC tubing, with pinch clamps |
| 20816203022435 | Spike port to six male luers. Singly pouched, 12 per case. |