CueSee VeriSTAT® AN01902A04

GUDID 08718734962632

CueSee VeriSTAT® LV 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. CueSee VeriSTAT® LV contains: 1 bottle of CueSee VeriSTAT® LV1 (DI: 08718734962557), 1 bottle of CueSee VeriSTAT® LV2 (DI: 08718734962564), 1 bottle of CueSee VeriSTAT® LV3 (DI: 08718734962571), 1 bottle of CueSee VeriSTAT® LV4 (DI: 08718734962588), 1 bottle of CueSee VeriSTAT® LV5 (DI: 08718734962595),

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Primary Device ID08718734962632
NIH Device Record Key1bd2c1a8-c1e7-4d1c-aa66-91fd703b7cf1
Commercial Distribution StatusIn Commercial Distribution
Brand NameCueSee VeriSTAT®
Version Model NumberLV
Catalog NumberAN01902A04
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 Datetrue
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
GS108718734962632 [Primary]

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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