CueSee VeriSTAT® AN01902A02

GUDID 08718734962618

CueSee VeriSTAT® S2 is an unassayed quality control material for professional use to verify the performance characteristics of the Abbott i-STAT® system analyzer. The device is intended for the quantitative determination of blood gases (pH, pO2, pCO2), electrolytes (Na+, K+, Ca2+, Cl-), metabolites (glucose, lactate, creatinine, urea), tCO2 and hematocrit.

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08718734962618
NIH Device Record Key12522053-4c5f-4cae-8927-ad8b9d70ee2a
Commercial Distribution StatusIn Commercial Distribution
Brand NameCueSee VeriSTAT®
Version Model NumberS2
Catalog NumberAN01902A02
Company DUNS412925992
Company NameEurotrol B.V.
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108718734962533 [Primary]
GS108718734962618 [Package]
Contains: 08718734962533
Package: Box [5 Units]
In Commercial Distribution

FDA Product Code

OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-06
Device Publish Date2024-10-29

On-Brand Devices [CueSee VeriSTAT®]

08718734962632CueSee VeriSTAT® LV is an unassayed quality control material for professional use to verify the
08718734962625CueSee VeriSTAT® S3 is an unassayed quality control material for professional use to verify the
08718734962618CueSee VeriSTAT® S2 is an unassayed quality control material for professional use to verify the
08718734962526CueSee VeriSTAT® S1 is an unassayed quality control material for professional use to verify the

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