MIR

GUDID 08052990321049

Desktop base spirometer and oximeter for lung function testing

MIR MEDICAL INTERNATIONAL RESEARCH SPA

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• Primary Device ID: 08052990321049
• NIH Device Record Key: 122ca5b7-4e1b-400c-89ca-ded067c69ba0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIR
• Version Model Number: Spirolab New spirometer + oximeter
• 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: true
• 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
• 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
• Phone: +390622754777
• Email: gerda.v@spirometry.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	08052990321049 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061875

FDA Product Code

• BZG: Spirometer, Diagnostic

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2024-01-09
• Device Publish Date: 2023-01-20

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