Primary Device ID | B800430105 |
NIH Device Record Key | e3055ec2-046e-4e0c-b537-e21f148d1072 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Antifungals Level 1 |
Version Model Number | 43010 |
Catalog Number | 43010 |
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 | B800430100 [Primary] |
HIBCC | B800430105 [Package] Contains: B800430100 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 |
B800430105 | Antifungals Level 1 |
B800AFUNGL1SFMAYO5 | ANTIFUNGALS LEVEL 1 |
B800ANTIF1SWDL5 | ANTIFUNGALS LEVEL 1 |
B800AFUNGL1SFUW6 | ANTIFUNGALS LEVEL 1 |
B800ANTIF1SUPHS5 | ANTIFUNGALS LEVEL 1 |