CueSee® VeriSTAT LVM

GUDID 08718734961468

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 - 08718734961413 CueSee® VeriSTAT LVM Level 2 - 08718734961420 CueSee® VeriSTAT LVM Level 3 - 08718734961437 CueSee® VeriSTAT LVM Level 4 - 08718734961444 CueSee® VeriSTAT LVM Level 5 - 08718734961451

Eurotrol B.V.

Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

• Primary Device ID: 08718734961468
• NIH Device Record Key: 97274094-dc1f-4ba2-b4d7-83be916cc6ac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® VeriSTAT LVM
• Version Model Number: 220.000.005
• 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	08718734961468 [Primary]

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

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