M914, Medikro® Primo

GUDID 06420099000516

Medikro Oy

Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional Diagnostic spirometer, professional

• Primary Device ID: 06420099000516
• NIH Device Record Key: cb044e7e-a99f-43f9-b6c7-8e80f35a437b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M914, Medikro® Primo
• Version Model Number: M9492
• Company DUNS: 369263660
• Company Name: Medikro Oy
• 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: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06420099000516 [Package]; Contains: 06420099000851; Package: [1 Units]; In Commercial Distribution
GS1	06420099000851 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133428

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: 2018-08-13
• Device Publish Date: 2018-07-13

Devices Manufactured by Medikro Oy

• 06420099001117 - M9256-PCD, Disposable Flow Transducer, 100 pcs: 2020-03-23
• 06420099000554 - M9256, SpiroSafe Disposable Flow Transducer: 2020-03-23
• 06420099000561 - M9256, SpiroSafe Disposable Flow Transducer: 2020-03-23
• 06420099001087 - M915-PCD, PCD Spirometer Kit: 2019-12-09
• 06420099001124 - M9264-PCD-200, Pressure Tube: 2019-12-09
• 06420099000387 - M9474, Medikro® Calibration Syringe, 3000 ml: 2018-08-13
• 06420099000486 - M9264-200, Pressure Tube: 2018-08-13
• 06420099000677 - M9227, Nose Clip: 2018-08-13