| Primary Device ID | B800DOA3EXTBUFOFFMMC5 |
| NIH Device Record Key | 7b71baa0-26d9-4abf-ba07-e6fd932c090c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DRUGS OF ABUSE LEVEL 3 |
| Version Model Number | DOA 3 EXTBUF OF F MMC |
| Catalog Number | DOA 3 EXTBUF OF F MMC |
| 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 |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 Milliliter |
| Total Volume | 3 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 |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800DOA3EXTBUFOFFMMC0 [Primary] |
| HIBCC | B800DOA3EXTBUFOFFMMC5 [Package] Contains: B800DOA3EXTBUFOFFMMC0 Package: BOX [17 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 | 2025-01-20 |
| Device Publish Date | 2025-01-10 |
| B80002041000031 | DRUGS OF ABUSE LEVEL 3 |
| B800DA3WBFRIDH5 | DRUGS OF ABUSE LEVEL 3 |
| B800DAUCAL3V3FNHI5 | DRUGS OF ABUSE LEVEL 3 |
| B800DAU3V2FUVMG0 | DRUGS OF ABUSE LEVEL 3 |
| B800DAU3FLE5 | DRUGS OF ABUSE LEVEL 3 |
| B800DOA3SMXOFMMC5 | DRUGS OF ABUSE LEVEL 3 |
| B800SMXDAU3FPG5 | DRUGS OF ABUSE LEVEL 3 |
| B800SMXDAU3V2FPG5 | DRUGS OF ABUSE LEVEL 3 |
| B800DAU3FOSUMC5 | DRUGS OF ABUSE LEVEL 3 |
| B800DAU3NJSP5 | DRUGS OF ABUSE LEVEL 3 |
| B800DOA3EXTBUFOFFMMC5 | DRUGS OF ABUSE LEVEL 3 |