| Primary Device ID | 10816203020045 |
| NIH Device Record Key | 6ad5e7ea-1202-4d85-a7d8-9fe16b9b62fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Needle Free Spike |
| Version Model Number | CBS |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10816203020045 [Primary] |
| GS1 | 20816203020042 [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 | 2025-06-18 |
| Device Publish Date | 2016-09-23 |
| 10816203023800 - Accessories | 2025-06-26 DMSO-Resistant Bag Spike with needle injection port |
| 20816203023845 - Accessories | 2025-06-26 Needle-free vial spike, DMSO-resistant |
| 20816203023852 - Accessories | 2025-06-26 3ml syringe on a female luer with 15cm of SCD tubing |
| 20816203023869 - Accessories | 2025-06-26 6 mL syringe with 5 mL of air on a female luer with 15cm sealed SCD tubing |
| 20816203023876 - Accessories | 2025-06-26 12ml syringe on a female luer with 15cm sealed SCD tubing |
| 20816203023883 - Accessories | 2025-06-26 20ml syringe on a female luer with 15cm sealed SCD tubing |
| 20816203023906 - CryoStore Freezing Bag | 2025-06-26 CryoStore 25 EVA Freezing Bag, 10-25ml, "F" Tube Set, singly packed |
| 20816203023913 - O-Wrap™ Bag | 2025-06-26 O-Wrap, overwrap pouch for freezing, 9x9cm |