CueSee® VeriSTAT QC 221.002.010

GUDID 08718734961512

CueSee® VeriSTAT QC - Level 2 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 ID: 08718734961512
• NIH Device Record Key: 8fa92cd3-31d6-431f-965a-0977ce409773
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® VeriSTAT QC
• Version Model Number: Level 2
• Catalog Number: 221.002.010
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08718734961482 [Primary]
GS1	08718734961512 [Package]; Contains: 08718734961482; Package: Product Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131595

FDA Product Code

• JJY: Multi-Analyte Controls, All Kinds (Assayed)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-16
• Device Publish Date: 2020-10-08

On-Brand Devices [CueSee® VeriSTAT QC]

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