| Primary Device ID | G507M400F01000 |
| NIH Device Record Key | 8ef41ae1-1bd0-4187-a870-498fefd1aca7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | M4:BaseF™ |
| Version Model Number | M400F0100 |
| Catalog Number | M400F0100 |
| 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 | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com | |
| Phone | 210-877-0100 |
| info@incell.com |
| 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 |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Handling 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 |
|---|---|
| HIBCC | G507M400F01000 [Primary] |
| KIT | Media And Components, Synthetic Cell And Tissue Culture |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-08-19 |
| Device Publish Date | 2025-08-11 |
| G507M400F05000 | Supplemented Xeno Free Cell Culture Growth Media without Antibiotics |
| G507M400F01000 | Supplemented Xeno Free Cell Culture Growth Media without Antibiotics |