CueSee® VeriSTAT QC - CueSee® VeriSTAT QC - Level 3 is an assayed - Eurotrol B.V.

Duns Number:412925992

Device Description: CueSee® VeriSTAT QC - Level 3 is an assayed aqueous quality control material for professio CueSee® VeriSTAT QC - Level 3 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.

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More Product Details

Catalog Number

221.003.010

Brand Name

CueSee® VeriSTAT QC

Version/Model Number

Level 3

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131595,K131595

Product Code Details

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

c000f22d-4f30-4361-8913-3d54a580607f

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Additional Identifiers

Package DI Number

08718734961529

Quantity per Package

10

Contains DI Package

08718734961499

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Product Box

"EUROTROL B.V." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 21
2 A medical device with a moderate to high risk that requires special controls. 15