Primary Device ID | B800FENT2UADX5 |
NIH Device Record Key | 601e2ec5-fd33-4a27-8311-4d7f3761662d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FENTANYL PLUS LEVEL 2 |
Version Model Number | FENT+ 2 U ADX |
Catalog Number | FENT+ 2 U ADX |
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 | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com | |
Phone | 8888825522 |
welovecontrol@utak.com |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Total Volume | 10 Milliliter |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Issuing Agency | Device ID |
---|---|
HIBCC | B800FENT2UADX0 [Primary] |
HIBCC | B800FENT2UADX5 [Package] Contains: B800FENT2UADX0 Package: BOX [10 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 | 2024-07-31 |
Device Publish Date | 2024-07-23 |
B80003716500041 | FENTANYL PLUS LEVEL 2 |
B800FENT2QD5 | FENTANYL PLUS LEVEL 2 |
B800FENT2UFMAYO5 | FENTANYL PLUS LEVEL 2 |
B800FENT2UADX5 | FENTANYL PLUS LEVEL 2 |
B800FENT2WBNJSP5 | FENTANYL PLUS LEVEL 2 |
B800FENT2V2UNJSP5 | FENTANYL PLUS LEVEL 2 |