| Primary Device ID | B800430115 |
| NIH Device Record Key | a8f112b4-2ebe-4bef-acc1-a18193be1dbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Antifungals Level 2 |
| Version Model Number | 43011 |
| Catalog Number | 43011 |
| 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 |
| Total Volume | 5 Milliliter |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B800430110 [Primary] |
| HIBCC | B800430115 [Package] Contains: B800430110 Package: Box [5 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 | 2020-04-23 |
| Device Publish Date | 2020-04-15 |
| B800430115 | Antifungals Level 2 |
| B800AFUNGL2SFMAYO5 | ANTIFUNGALS LEVEL 2 |
| B800ANTIF2SWDL5 | ANTIFUNGALS LEVEL 2 |
| B800AFUNGL2SFUW5 | ANTIFUNGALS LEVEL 2 |
| B800ANTIF2SUPHS5 | ANTIFUNGALS LEVEL 2 |