FENTANYL PLUS LEVEL 1 FENT+ 1 WB NJSP

GUDID B800FENT1WBNJSP5

FENTANYL PLUS LEVEL 1

UTAK LABORATORIES, INC.

Multiple-type clinical chemistry analyte profile IVD, control
Primary Device IDB800FENT1WBNJSP5
NIH Device Record Key8226e550-7297-4ff1-ad61-d9df4bfed223
Commercial Distribution StatusIn Commercial Distribution
Brand NameFENTANYL PLUS LEVEL 1
Version Model NumberFENT+ 1 WB NJSP
Catalog NumberFENT+ 1 WB NJSP
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 Datetrue
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

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB800FENT1WBNJSP0 [Primary]
HIBCCB800FENT1WBNJSP5 [Package]
Contains: B800FENT1WBNJSP0
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 Date2024-09-26
Device Publish Date2024-09-18

On-Brand Devices [FENTANYL PLUS LEVEL 1 ]

B80003716500031FENTANYL PLUS LEVEL 1
B800FENT1QD5FENTANYL PLUS LEVEL 1
B800FENT1UFMAYO5FENTANYL PLUS LEVEL 1
B800FENT1UADX5FENTANYL PLUS LEVEL 1
B800FENT1WBNJSP5FENTANYL PLUS LEVEL 1
B800FENT1V2UNJSP5FENTANYL PLUS LEVEL 1

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