Thermo Scientific GlucoCrush™

GUDID 00845275006544

Fisher Diagnostics

Glucose IVD, reagent
Primary Device ID00845275006544
NIH Device Record Keyec06688a-5f6d-44ac-b8e4-1efac0769834
Commercial Distribution StatusIn Commercial Distribution
Brand NameThermo Scientific GlucoCrush™
Version Model NumberB2495-10A
Company DUNS183998769
Company NameFisher Diagnostics
Device Count6
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
GS100845275006544 [Primary]
GS100845275006636 [Unit of Use]
GS100845275006728 [Package]
Package: [4 Units]
In Commercial Distribution

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 GlucoCrush™]

00845275006629B2495-9A
00845275006612B2495-7A
00845275006605B2495-6A
00845275006599B2495-5A
00845275006582B2495-4A
00845275006575B2495-3A
00845275006568B2495-2A
00845275006551B2495-1A
00845275006544B2495-10A

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