CoaguChek Vantus 08238359001

GUDID 00365702702356

Roche Diagnostics GmbH

Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered Coagulation analyser IVD, point-of-care, battery-powered

• Primary Device ID: 00365702702356
• NIH Device Record Key: f9b0e2e8-eb59-4c85-a71e-8dc913721c54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CoaguChek Vantus
• Version Model Number: 08238359001
• Catalog Number: 08238359001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: 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	00365702702356 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170960

FDA Product Code

• GJS: TEST, TIME, PROTHROMBIN

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: 2023-12-11
• Device Publish Date: 2023-12-01

Devices Manufactured by Roche Diagnostics GmbH

• 07613336224816 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224823 - ONLINE TDM Methotrexate: 2024-04-02
• 07613336224830 - MTX Calibrator: 2024-04-02
• 07613336217689 - Elecsys ProBNP II: 2024-02-27
• 04015630929702 - cobas Elecsys AntiTPO: 2024-02-16
• 04015630939626 - Elecsys Anti-TPO: 2024-02-16
• 04015630899548 - Elecsys CalSet TUptake: 2024-02-05
• 04015630899579 - Elecsys Tuptake Assay: 2024-02-05