| Primary Device ID | B800C1011L3V45 |
| NIH Device Record Key | bdf03b68-2a22-40d1-aed8-da17f47f55d0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CARBAMAZEPINE-10,11-EPOXIDE LEVEL 3 |
| Version Model Number | C1011 L3 V4 |
| Catalog Number | C1011 L3 V4 |
| 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 | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 Milliliter |
| Total Volume | 0.5 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 | B800C1011L3V40 [Primary] |
| HIBCC | B800C1011L3V45 [Package] Contains: B800C1011L3V40 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 |
| B800ANTIF2SQD5 - ANTIFUNGALS LEVEL 2 | 2026-02-16 ANTIFUNGALS LEVEL 2 |
| B800ANLCCALMFFCCO5 - ANLC CAL | 2026-02-13 ANLC CAL |
| B800CONTROL1V2SSH5 - MIXED CONTROL LEVEL 1 V2 | 2026-02-13 MIXED CONTROL LEVEL 1 V2 |
| B800CONTROL2V2SSH0 - MIXED CONTROL LEVEL 2 V2 | 2026-02-13 MIXED CONTROL LEVEL 2 V2 |
| B800DAUCONT1V2FRX5 - DAU CONTROL LEVEL 1 V2 | 2026-02-13 DAU CONTROL LEVEL 1 V2 |
| B800DAUCONT2V2FRX0 - DAU CONTROL LEVEL 2 V2 | 2026-02-13 DAU CONTROL LEVEL 2 V2 |
| B800EIACAL2V2UFRX5 - EIA CAL LEVEL 2 V2 | 2026-02-13 EIA CAL LEVEL 2 V2 |
| B800EIACALLEVEL1V25 - EIA CAL LEVEL 1 V2 | 2026-02-13 EIA CAL LEVEL 1 V2 |