FENTANYL PLUS LEVEL 1

GUDID B80003716500031

Opiate/opiate metabolite IVD, control

Primary Device ID	B80003716500031
NIH Device Record Key	c3eff60e-51c6-4a8c-bd13-d74f833b968b
Commercial Distribution Status	In Commercial Distribution
Brand Name	FENTANYL PLUS LEVEL 1
Version Model Number	FENT+ 1 U PM
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

Device Issuing Agency	Device ID
HIBCC	B80003716500030 [Primary]
HIBCC	B80003716500031 [Package] Contains: B80003716500030 Package: Box [4 Units] In Commercial Distribution
HIBCC	B80003716500032 [Package] Contains: B80003716500030 Package: Box [5 Units] In Commercial Distribution
HIBCC	B80003716500033 [Package] Contains: B80003716500030 Package: Box [10 Units] In Commercial Distribution
HIBCC	B80003716500036 [Package] Contains: B80003716500030 Package: Box [25 Units] In Commercial Distribution
HIBCC	B80003716500037 [Package] Contains: B80003716500030 Package: Box [50 Units] In Commercial Distribution
HIBCC	B80003716500038 [Package] Contains: B80003716500030 Package: Box [100 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false