M914, Medikro® Primo

GUDID 06420099000516

Medikro Oy

Diagnostic spirometer

• 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