FENTANYL PLUS FENT+ U F ODX

GUDID B800FENTUFODX5

Multiple-type clinical chemistry analyte profile IVD, control

Primary Device ID	B800FENTUFODX5
NIH Device Record Key	fe4fe79a-53d5-412c-9e71-9f65141dfdeb
Commercial Distribution Status	In Commercial Distribution
Brand Name	FENTANYL PLUS
Version Model Number	FENT+ U F ODX
Catalog Number	FENT+ U F ODX
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

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	B800FENTUFODX0 [Primary]
HIBCC	B800FENTUFODX5 [Package] Contains: B800FENTUFODX0 Package: BOX [25 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B800ACETAHIGHV2UADX5 - ACETAMINOPHEN PLUS HIGH V2	2026-01-26 ACETAMINOPHEN PLUS HIGH V2
B800ACETALOWV2UADX5 - ACETAMINOPHEN PLUS LOW V2	2026-01-26 ACETAMINOPHEN PLUS LOW V2
B800MOR225UKP5 - MORPHINE 225 NG/ML	2026-01-26 MORPHINE 225 NG/ML
B800AMPH60V2WBCP5 - AMPH PLUS 60 NG/ML V2	2026-01-21 AMPH PLUS 60 NG/ML V2
B800DAUL3UFVMCI5 - DRUGS OF ABUSE LEVEL 3	2026-01-21 DRUGS OF ABUSE LEVEL 3
B800FENTUFODX5 - FENTANYL PLUS	2026-01-14 FENTANYL PLUS
B800FENTUFODX5 - FENTANYL PLUS	2026-01-14 FENTANYL PLUS
B800AMPQC1URIH5 - AMPHETAMINE LEVEL 1	2025-12-23 AMPHETAMINE LEVEL 1
B800AMPQC2URIH5 - AMPHETAMINE LEVEL 2	2025-12-23 AMPHETAMINE LEVEL 2