Thermo Scientific Trutol™

GUDID 00845275004113

Fisher Diagnostics

Glucose IVD, reagent
Primary Device ID00845275004113
NIH Device Record Key3682669f-c43f-4da6-8669-6698b140732f
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermo Scientific Trutol™
Version Model Number401526P
Company DUNS183998769
Company NameFisher Diagnostics
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-528-0494
Emailxx@xx.xx

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100845275004113 [Primary]
GS100845275006070 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRVDrink, Glucose Tolerance

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-19
Device Publish Date2016-09-16

On-Brand Devices [Thermo Scientific Trutol™]

00845275004823401272PA
00845275004809401223PS
00845275004793401223PA
00845275004120401576P
00845275004113401526P
00845275004106401503P
00845275004090401272P
00845275004083401223P
00845275004076401207P
00845275004069401074P
00845275004052401025P
00845275004045401009P

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