DRUGS OF ABUSE LEVEL 4 DA 4 WB F RIDH

GUDID B800DA4WBFRIDH5

DRUGS OF ABUSE LEVEL 4

UTAK LABORATORIES, INC.

Multiple therapeutic drugs/drugs of abuse IVD, control
Primary Device IDB800DA4WBFRIDH5
NIH Device Record Key438d865b-522d-4ce8-ac98-c7edc5e0e3d2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRUGS OF ABUSE LEVEL 4
Version Model NumberDA 4 WB F RIDH
Catalog NumberDA 4 WB F RIDH
Company DUNS092519016
Company NameUTAK LABORATORIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com
Phone1-888-882-5522
Emailwelovecontrol@utak.com

Device Dimensions

Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter
Total Volume1 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800DA4WBFRIDH0 [Primary]
HIBCCB800DA4WBFRIDH5 [Package]
Contains: B800DA4WBFRIDH0
Package: Box [25 Units]
In Commercial Distribution

FDA Product Code

LASDrug Specific Control Materials

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-13
Device Publish Date2023-02-03

On-Brand Devices [DRUGS OF ABUSE LEVEL 4]

B800DA4WBFRIDH5DRUGS OF ABUSE LEVEL 4
B800DAUCAL4V3FNHI0DRUGS OF ABUSE LEVEL 4
B800DAU4FLE5DRUGS OF ABUSE LEVEL 4
B800DAU4NJSP5DRUGS OF ABUSE LEVEL 4

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