CueSee® Coag 340.001.005

GUDID 08718734962779

CueSee® Coag is an unassayed quality control material intended to verify the precision of prothrombin time (PT), International Normalized Ratio (INR), activated clotting time (ACT) and/or activated partial thromboplastin time (aPTT) measurements on coagulation analyzers in the clinically relevant range. For laboratory and near-patient (point-of-care) testing by healthcare professionals.

Eurotrol B.V.

Multiple coagulation factor IVD, control

• Primary Device ID: 08718734962779
• NIH Device Record Key: 5650dfc6-0c94-4bcb-8db7-dfc64f9a3ca9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CueSee® Coag
• Version Model Number: 1
• Catalog Number: 340.001.005
• Company DUNS: 412925992
• Company Name: Eurotrol B.V.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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	08718734962724 [Primary]
GS1	08718734962779 [Package]; Contains: 08718734962724; Package: Box [5 Units]; In Commercial Distribution

FDA Product Code

• GGN: Plasma, Coagulation Control

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: 2025-04-16
• Device Publish Date: 2025-04-08

On-Brand Devices [CueSee® Coag]

• 08718734962816: CueSee® Coag is an unassayed quality control material intended to verify the precision of proth
• 08718734962809: CueSee® Coag is an unassayed quality control material intended to verify the precision of proth
• 08718734962793: CueSee® Coag is an unassayed quality control material intended to verify the precision of proth
• 08718734962786: CueSee® Coag is an unassayed quality control material intended to verify the precision of proth
• 08718734962779: CueSee® Coag is an unassayed quality control material intended to verify the precision of proth