| Primary Device ID | 00893727002132 |
| NIH Device Record Key | 55edf47a-3352-4ddc-b6e2-317995d3c26c |
| Commercial Distribution Discontinuation | 2021-12-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Embryo Biopsy Medium |
| Version Model Number | 90103-2X20mL |
| Catalog Number | 90103 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| Device Count | 2 |
| 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 | true |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| 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 | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Total Volume | 20 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00893727002132 [Primary] |
| GS1 | 18937270021321 [Unit of Use] |
| MQL | Media, Reproductive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2021-08-18 |
| Device Publish Date | 2016-09-10 |
| 00893727002002 - Oil for Embryo Culture | 2025-06-16 Oil for Embryo Culture |
| 00893727002019 - PBS 1X - Dulbecco's Phosphate Buffered Saline Solution | 2025-06-16 PBS 1X Dulbecco's |
| 00893727002071 - Sperm Washing Medium | 2025-06-16 Sperm Washing Medium |
| 00893727002088 - Sperm Washing Medium | 2025-06-16 Sperm Washing Medium |
| 00893727002101 - Human Serum Albumin Solution | 2025-06-16 Human Serum Albumin Solution |
| 00893727002125 - Hyaluronidase Solution | 2025-06-16 Hyaluronidase |
| 00893727002163 - 7% PVP Solution with HSA | 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 7% |
| 00893727002170 - 10% PVP Solution with HSA | 2025-06-16 Polyvinylpyrrolidone (PVP) Solution with HSA - 10% |