CueSee® VeriSTAT LVM - CueSee® VeriSTAT LVM is an assayed aqueous blood - Eurotrol B.V.

Duns Number:412925992

Device Description: CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control m CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.A box of CueSee® VeriSTAT LVM contains 5 levels of control material:CueSee® VeriSTAT LVM Level 1 - 08718734961413CueSee® VeriSTAT LVM Level 2 - 08718734961420CueSee® VeriSTAT LVM Level 3 - 08718734961437CueSee® VeriSTAT LVM Level 4 - 08718734961444CueSee® VeriSTAT LVM Level 5 - 08718734961451

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More Product Details

Catalog Number

-

Brand Name

CueSee® VeriSTAT LVM

Version/Model Number

220.000.005

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

Product Code Details

Product Code

JJY

Product Code Name

Multi-Analyte Controls, All Kinds (Assayed)

Device Record Status

Public Device Record Key

97274094-dc1f-4ba2-b4d7-83be916cc6ac

Public Version Date

October 16, 2020

Public Version Number

1

DI Record Publish Date

October 08, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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