Eurotrol GlucoTrol-NG 170.002.002

GUDID 08718734960560

Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verification of the precision and accuracy of HemoCue® Glucose systems.

Eurotrol B.V.

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Primary Device ID08718734960560
NIH Device Record Keyd1ab786e-0a47-414e-80a3-2297f1cf7302
Commercial Distribution StatusIn Commercial Distribution
Brand NameEurotrol GlucoTrol-NG
Version Model NumberGlucoTrol-NG Level 2
Catalog Number170.002.002
Company DUNS412925992
Company NameEurotrol B.V.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960553 [Package]
Package: Product Box [2 Units]
In Commercial Distribution
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]
GS108718734960560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [Eurotrol GlucoTrol-NG ]

08718734960591Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific
08718734960577Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific
08718734960560Eurotrol GlucoTrol-NG is an assayed glucose control intended for professional use in the verific

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