CueSee® VeriSTAT QC 221.001.010

GUDID 08718734961505

CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT QC - Level 1 should be used in the periodic verification of the precision, accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08718734961505
NIH Device Record Key712ed645-f816-4176-a1f5-376a71fdae2d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCueSee® VeriSTAT QC
Version Model NumberLevel 1
Catalog Number221.001.010
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961475 [Primary]
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution
GS108718734961505 [Package]
Contains: 08718734961475
Package: Product Box [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)
JJYMulti-Analyte Controls, All Kinds (Assayed)

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 [CueSee® VeriSTAT QC]

08718734961529CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professional u
08718734961512CueSee® VeriSTAT QC - Level 2 is an assayed aqueous quality control material for professional u
08718734961505CueSee® VeriSTAT QC - Level 1 is an assayed aqueous quality control material for professional u

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