| Primary Device ID | 00805360016865 |
| NIH Device Record Key | fac96540-5596-4a63-bfc4-4859f88f4765 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Enhance Sperm Wash w/ Gentamicin |
| Version Model Number | 15263 |
| Company DUNS | 051915038 |
| Company Name | VITROLIFE 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 | 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 |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Total Volume | 100 Milliliter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00805360016865 [Primary] |
| MQL | Media, Reproductive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-11-11 |
| Device Publish Date | 2018-04-20 |
| 00805360016865 - Enhance Sperm Wash w/ Gentamicin | 2024-11-111-(500ml) Enhance Sperm Wash w/ Gentamicin |
| 00805360016865 - Enhance Sperm Wash w/ Gentamicin | 2024-11-11 1-(500ml) Enhance Sperm Wash w/ Gentamicin |
| 10805360014103 - Handling Pipette | 2021-09-13 |
| 10805360014110 - Handling Pipette | 2021-09-13 |
| 10805360014127 - Handling Pipette | 2021-09-13 |
| 10805360014141 - Handling Pipette | 2021-09-13 |
| 10805360014158 - Handling Pipette | 2021-09-13 |
| 10805360014165 - Handling Pipette | 2021-09-13 |
| 10805360014172 - Handling Pipette | 2021-09-13 |