| Primary Device ID | B800BUSQC1FCMH5 |
| NIH Device Record Key | 78a7f484-5e85-4dec-867b-3404f49faa94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BUSULFAN LEVEL 1 |
| Version Model Number | BUS QC 1 F CMH |
| Catalog Number | BUS QC 1 F CMH |
| 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 |
| 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 |
| 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 |
| 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 | B800BUSQC1FCMH0 [Primary] |
| HIBCC | B800BUSQC1FCMH5 [Package] Contains: B800BUSQC1FCMH0 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 | 2025-02-20 |
| Device Publish Date | 2025-02-12 |
| B80001696000071 | BUSULFAN LEVEL 1 |
| B800BUS1DPFDU5 | BUSULFAN LEVEL 1 |
| B800BUS1DPUPMC5 | BUSULFAN LEVEL 1 |
| B800BUS1PFNIH5 | BUSULFAN LEVEL 1 |
| B800BUSC1MAYO0 | BUSULFAN LEVEL 1 |
| B800BUSQC1FCMH5 | BUSULFAN LEVEL 1 |