| Primary Device ID | 10816203021967 |
| NIH Device Record Key | 320dd31b-eb3d-41e8-b9e9-b9832ab70d37 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Spike Adapter |
| Version Model Number | SM |
| 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 | true |
| 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 | |
| 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 | |
| Phone | 512-474-7278 |
| regulatory@origen.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203021967 [Primary] |
| GS1 | 20816203021964 [Package] Package: Case [50 Units] 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 | 2021-02-19 |
| Device Publish Date | 2016-09-23 |
| 10816203022469 | One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203022384 | One spike to one spike with 10cm of SCD tubing and pinch clamp, case of 50 |
| 10816203021967 | One spike with male to male luer, case of 50 |
| 10816203021936 | One spike to one spike with 50cm of SCD tubing and pinch clamp, case of 50 |
| 10816203021929 | One spike to one female luer with 15cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203021912 | One spike to one 3/8" barb with 12cm DMSO resistant tubing |
| 10816203020588 | One spike to one male luer with 150cm tubing and roller clamp |
| 10816203020274 | One spike to 1 male luer w/50cm SCD tubing & roller clamp |
| 20816203020264 | One spike to one male luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203020250 | One spike to one male luer with 10cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203020243 | One spike to one female luer with 50cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203020236 | One spike to one female luer with 10cm DMSO resistant tubing and pinch clamp, case of 50 |
| 10816203020632 | One spike to a needle-free valve to one spike and two male luers with 40cm tubing and roller cla |
| 10816203021615 | One female luer to eight spikes with 100cm of SCD tubing and pinch clamps, case of 20 |