PETH LEVEL 2 PETH 2 K2WB F UM

GUDID B800PETH2K2WBFUM5

Multiple drugs of abuse IVD, control

Primary Device ID	B800PETH2K2WBFUM5
NIH Device Record Key	8cb99381-1394-4864-b771-eee28969cbbd
Commercial Distribution Status	In Commercial Distribution
Brand Name	PETH LEVEL 2
Version Model Number	PETH 2 K2WB F UM
Catalog Number	PETH 2 K2WB F UM
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
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	B800PETH2K2WBFUM0 [Primary]
HIBCC	B800PETH2K2WBFUM5 [Package] Contains: B800PETH2K2WBFUM0 Package: BOX [25 Units] In Commercial Distribution

LAS	Drug Specific Control Materials

Steralize Prior To Use	false
Device Is Sterile	false

B800PETH2WBFUCSD0	PETH LEVEL 2
B800PETH2K2WBFUM5	PETH LEVEL 2