MIR

GUDID 08052990321711

Smart Spirometer and Oximeter connected to an app available on a smart phone

MIR MEDICAL INTERNATIONAL RESEARCH SPA

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• Primary Device ID: 08052990321711
• NIH Device Record Key: 3d08bdda-d6e5-43a8-a551-ed6ea2c1661a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIR
• Version Model Number: Spirobank Oxi
• Company DUNS: 630129930
• Company Name: MIR MEDICAL INTERNATIONAL RESEARCH SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• 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

Customer Support Contacts

• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com
• Phone: +390622754777
• Email: gerda.v@spirometry.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052990321711 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230501

FDA Product Code

• BZG: Spirometer, Diagnostic

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: 2024-01-12
• Device Publish Date: 2024-01-04

On-Brand Devices [MIR]

• 08052990321049: Desktop base spirometer and oximeter for lung function testing
• 08052990321711: Smart Spirometer and Oximeter connected to an app available on a smart phone