CoaguChek Vantus 08238359001

GUDID 00365702702356

Roche Diagnostics GmbH

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

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