| Primary Device ID | B800ETOHII07245 |
| NIH Device Record Key | f03e3ef8-5f05-4376-8acb-d08dcb0913fd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ETOH II_07 24 |
| Version Model Number | ETOH II_07 24 |
| Catalog Number | ETOH II_07 24 |
| 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 |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 Milliliter |
| Total Volume | 1.25 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800ETOHII07240 [Primary] |
| HIBCC | B800ETOHII07245 [Package] Contains: B800ETOHII07240 Package: BOX [25 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 | 2024-06-28 |
| Device Publish Date | 2024-06-20 |
| B800NICO100V3UFUWHC5 - NICOTINE PLUS 100 NG/ML V3 | 2024-07-11 NICOTINE PLUS 100 NG/ML V3 |
| B800NICO1200V3UFUWHC5 - NICOTINE PLUS 1200 NG/ML V3 | 2024-07-11 NICOTINE PLUS 1200 NG/ML V3 |
| B800THCV2SWSLH5 - THC PLUS | 2024-07-11 THC PLUS |
| B800DA1WBIMMUN5 - DRUGS OF ABUSE PLUS LEVEL 1 | 2024-07-09 DRUGS OF ABUSE PLUS LEVEL 1 |
| B800DA2WBIMMUN0 - DRUGS OF ABUSE PLUS LEVEL 2 | 2024-07-09 DRUGS OF ABUSE PLUS LEVEL 2 |
| B800DA3WBIMMUN0 - DRUGS OF ABUSE PLUS LEVEL 3 | 2024-07-09 DRUGS OF ABUSE PLUS LEVEL 3 |
| B800DA4WBIMMUN5 - DRUGS OF ABUSE PLUS LEVEL 4 | 2024-07-09 DRUGS OF ABUSE PLUS LEVEL 4 |
| B800BENZOYL1FAPTC5 - BENZOYLECGONINE LEVEL 1 | 2024-07-08 BENZOYLECGONINE LEVEL 1 |