| Primary Device ID | 00893727002989 |
| NIH Device Record Key | c2bed42b-99b3-4df1-a632-c176532e2ef6 |
| Commercial Distribution Discontinuation | 2023-03-31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Polyvinylpyrrolidone (PVP) - Lyophilized |
| Version Model Number | 99219-10x1mL |
| Catalog Number | 99219 |
| Company DUNS | 057475246 |
| Company Name | FUJIFILM IRVINE SCIENTIFIC, INC. |
| Device Count | 10 |
| 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 | 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 | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 Milliliter |
| Total Volume | 1 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 |
| 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 | 00893727002989 [Primary] |
| GS1 | 10893727002986 [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 | 2022-01-06 |
| Device Publish Date | 2016-09-10 |
| 00893727002934 - Modified Ham's F-10 with Albumin | 2024-02-12 Modified Ham's F-10 w/Albumin |
| 00893727002941 - Modified Ham's F-10 with Albumin | 2024-02-12 Modified Ham's F-10 w/Albumin |
| 00893727002835 - Modified Ham's F-10 Basal Medium - HEPES | 2023-12-08 Modified Ham's F-10 Basal Medium - HEPES |
| 00857515006337 - Heavy Oil for Embryo Culture | 2022-07-21 Heavy Oil for Embryo Culture |
| 00857515006344 - Heavy Oil for Embryo Culture | 2022-07-21 Heavy Oil for Embryo Culture |
| 00893727002248 - Early Cleavage Medium | 2022-03-31 Early Cleavage Medium (ECM) with Gentamicin |
| 00893727002989 - Polyvinylpyrrolidone (PVP) - Lyophilized | 2022-01-06PVP (polyvinylpyrrolidone) |
| 00893727002989 - Polyvinylpyrrolidone (PVP) - Lyophilized | 2022-01-06 PVP (polyvinylpyrrolidone) |
| 00893727002286 - Complete Early Cleavage Medium with DSS | 2021-10-20 Complete Early Cleavage (ECM) With DSS |