| Primary Device ID | B800DAUL1FKA5 |
| NIH Device Record Key | 33f88b4c-5235-42dd-92e2-58463fcb0914 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRUGS OF ABUSE LEVEL 1 |
| Version Model Number | DAU L1 F KA |
| Catalog Number | DAU L1 F KA |
| 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 | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com | |
| Phone | 1-888-882-5522 |
| welovecontrol@utak.com |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 5 Milliliter |
| Total Volume | 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 | B800DAUL1FKA0 [Primary] |
| HIBCC | B800DAUL1FKA5 [Package] Contains: B800DAUL1FKA0 Package: Box [10 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 | 2023-02-16 |
| Device Publish Date | 2023-02-08 |
| B800988185 | Drugs of Abuse Level 1 (WB) |
| B80002041000011 | DRUGS OF ABUSE LEVEL 1 |
| B800DA1WBFRIDH5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAUL1FKA5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAOF1FPM5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAUCAL1V3FNHI5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1V2FUVMG5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FAPS5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1V2SAPC5 | DRUGS OF ABUSE LEVEL 1 |
| B800DA1V2FWBTDHS5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FLE5 | DRUGS OF ABUSE LEVEL 1 |
| B800DA1SFLLS5 | DRUGS OF ABUSE LEVEL 1 |
| B800DOA1SMXOFMMC5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAUL1UFVMCI5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FMED5 | DRUGS OF ABUSE LEVEL 1 |
| B800SMXDAU1FPG5 | DRUGS OF ABUSE LEVEL 1 |
| B800DA1SSH5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAUQC1FMED5 | DRUGS OF ABUSE LEVEL 1 |
| B800SMXDAU1V2FPG5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FOSUMC5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FOL5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FSD5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1FHCMC5 | DRUGS OF ABUSE LEVEL 1 |
| B800DAU1V2FAPS5 | DRUGS OF ABUSE LEVEL 1 |