| Primary Device ID | G507ZSOLF05000 |
| NIH Device Record Key | 4f33e7e5-c9ef-44e7-bf98-9af686ab68eb |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ZSol:F™ |
| Version Model Number | ZSOLF0500 |
| Catalog Number | ZSOLF0500 |
| Company DUNS | 965420953 |
| Company Name | Incell Corporation, LLC |
| 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 | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com | |
| Phone | 800-364-1765 |
| info@incell.com |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Total Volume | 500 Milliliter |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Handling Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Storage Environment Temperature | Between 10 Degrees Celsius and 32 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G507ZSOLF05000 [Primary] |
| KIP | Formulations, Balanced Salt Solutions |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-09-14 |
| Device Publish Date | 2023-09-06 |
| G507ZEFR01000 - ZEFR™ | 2023-10-10 Chemically Defined Secretome Collection Media |
| G507EZNDHS05000 - EZ-CPZ-ND+2% Hetastarch (Hs)™ | 2023-09-15 Donor-organ/tissue/cell preservation solution |
| G507ZAPR01000 - ZAPR™ | 2023-09-14 Red Blood Cell Lysing Buffer |
| G507ZAPR04000 - ZAPR™ | 2023-09-14 Red Blood Cell Lysing Buffer |
| G507ZSOLF05000 - ZSol:F™ | 2023-09-14Bioprocessing Phosphate Buffer without Ca+2 and Mg+2 |
| G507ZSOLF05000 - ZSol:F™ | 2023-09-14 Bioprocessing Phosphate Buffer without Ca+2 and Mg+2 |
| G507EZCZ01000 - EZ-CPZ™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution |
| G507EZCZ05000 - EZ-CPZ™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution |
| G507EZND01000 - EZ-CPZ-ND™ | 2023-09-11 High Performance Cryopreservation Media and Storage Solution without DMSO |