| Primary Device ID | 60888937029408 |
| NIH Device Record Key | 705aebda-cb43-4b61-ab65-7984c7662130 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ORIGIO Gradient 40/80 |
| Version Model Number | 84022010M |
| Company DUNS | 801895244 |
| Company Name | Coopersurgical, Inc. |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Special Storage Condition, Specify | Between 0 and 0 *Protect from light |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 60888937029408 [Primary] |
| MQL | Media, Reproductive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-13 |
| Device Publish Date | 2026-02-05 |
| 60888937029415 | ORIGIO Gradient 40/80, 2x60 ml |
| 60888937029408 | ORIGIO Gradient 40/80, 2x10 ml |
| 60888937029392 | ORIGIO Gradient 40/80 12 x 10 ml |