| Primary Device ID | B800LEFLUHIGHL2V25 |
| NIH Device Record Key | 133fc7d3-7079-4df1-aaf0-74346560c41e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | LEFLUNOMIDE HIGH LEVEL 2 |
| Version Model Number | LEFLU HIGH L2 V2 |
| Catalog Number | LEFLU HIGH L2 V2 |
| Company DUNS | 092519016 |
| Company Name | UTAK LABORATORIES, INC. |
| 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 | false |
| 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 | false |
| OTC Over-The-Counter | false |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com | |
| Phone | 8888825522 |
| welovecontrol@utak.com |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Total Volume | 0.1 Milliliter |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and -10 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800LEFLUHIGHL2V20 [Primary] |
| HIBCC | B800LEFLUHIGHL2V25 [Package] Contains: B800LEFLUHIGHL2V20 Package: BOX [81 Units] In Commercial Distribution |
| LAS | Drug Specific Control Materials |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-05-08 |
| Device Publish Date | 2024-04-30 |
| B800LEFLUHIGHL25 | LEFLUNOMIDE HIGH LEVEL 2 |
| B800LEFLUHIGHL2V25 | LEFLUNOMIDE HIGH LEVEL 2 |