MIR 911102

GUDID 08052990321681

Peak low and FEV1 meter

MIR SRL MEDICAL INTERNATIONAL RESEARCH

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• Primary Device ID: 08052990321681
• NIH Device Record Key: 74f0f86e-07c2-45c6-96d4-e11927fcf0b7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIR
• Version Model Number: Smart One USA
• Catalog Number: 911102
• Company DUNS: 630129930
• Company Name: MIR SRL MEDICAL INTERNATIONAL RESEARCH
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

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
• 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	08052990321681 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181666

FDA Product Code

• BZH: Meter, Peak Flow, Spirometry

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: 2021-03-19
• Device Publish Date: 2018-11-22

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• 08052990321667: Desktop base spirometer for lung function testing
• 08052990321629: PC based spirometer for lung function testing
• 08052990320592: PC based spirometer for lung function testing
• 08052990321001: Desktop base spirometer for lung function testing
• 08052990320950: Portable spirometer and oximeter for lung function testing with Bluetooth smart technology
• 08052990320905: Portable spirometer for lung function testing with Bluetooth smart technology
• 08052990320738: Portable spirometer for lung function testing
• 08052990321759: Smart Spirometer connected to an app available on a smart phone
• 08052990320868: Portable spirometer for lung function testing with oximetry function with reusable turbine
• 08052990320851: Portable spirometer for lung function testing with oximetry function
• 08052990320790: Portable spirometer for lung function testing with reusable turbine
• 08052990320783: Portable spirometer for lung function testing.
• 08052990321681: Peak low and FEV1 meter
• 08052990321124: Smart Spirometer connected to an app available on a smart phone
• 08052990320653: PC based spirometer for lung function testing
• 08052990320578: Portable spirometer for lung function testing
• 08052990320523: Portable spirometer for lung function testing
• 08052990320486: Portable spirometer for lung function testing
• 08052990320448: Portable spirometer for lung function testing
• 08052990320356: Portable oximeter