M9256, SpiroSafe Disposable Flow Transducer

GUDID 06420099000554

Medikro Oy

Breathing mouthpiece, single-use

• Primary Device ID: 06420099000554
• NIH Device Record Key: b1407bc3-e1b5-4dea-80c7-e727f6401afd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: M9256, SpiroSafe Disposable Flow Transducer
• Version Model Number: M9256-100
• Company DUNS: 369263660
• Company Name: Medikro Oy
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	06420099000554 [Primary]
GS1	06420099000967 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133428

FDA Product Code

• BXP: Transducer, Gas Flow
• BYP: Mouthpiece, Breathing

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-03-23
• Device Publish Date: 2018-07-13

On-Brand Devices [M9256, SpiroSafe Disposable Flow Transducer]

• 06420099000561: M9256-SP-90
• 06420099000554: M9256-100