cobas infinity POC remote access 08420254001

GUDID 07613336157046

Roche Diagnostics GmbH

Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software Clinical laboratory information system application software

• Primary Device ID: 07613336157046
• NIH Device Record Key: a93d09d3-6cf3-435e-8ed1-c5d520003abd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: cobas infinity POC remote access
• Version Model Number: 08420254001
• Catalog Number: 08420254001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336157046 [Primary]

FDA Product Code

• JQP: Calculator/data processing module, for clinical use

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: 2020-12-29
• Device Publish Date: 2020-12-21

On-Brand Devices [cobas infinity POC remote access]

• 07613336157046: 08420254001
• 07613336192429: 09220763001