FlexLab

GUDID 07640172340004

The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sa

Inpeco SA

Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD, automated Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD Specimen processing instrument IVD

• Primary Device ID: 07640172340004
• NIH Device Record Key: 0db7ccee-b2bd-498f-9d67-15e52943bb12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexLab
• Version Model Number: FLX
• Company DUNS: 484880690
• Company Name: Inpeco SA
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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	07640172340004 [Primary]
GS1	7640172340509 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121012

FDA Product Code

• CEM: Electrode, Ion Specific, Potassium

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

Devices Manufactured by Inpeco SA

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• 07640172342008 - Aptio Automation: 2021-11-12 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in
• 07640172343005 - ProTube: 2020-09-21 The ProTube System is designed to automate biological sample collection process. ProTube ensures the biological sample collectio
• 07640172340004 - FlexLab: 2018-07-06The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sa
• 07640172340004 - FlexLab: 2018-07-06 The FlexLab Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling i
• 7640172341506 - Accelerator a3600: 2018-07-06 The Accelerator a3600 automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample
• 7640172342503 - Aptio Automation: 2018-07-06 The Aptio Automation is a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in