Hailie Sensor - for use only with Symbicort MDI

GUDID 09421032180415

Inhaler dose sensor

ADHERIUM (NZ) LIMITED

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• Primary Device ID: 09421032180415
• NIH Device Record Key: c6a4ccac-13bc-4f6b-b442-50968bc876c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hailie Sensor - for use only with Symbicort MDI
• Version Model Number: NF0108
• Company DUNS: 590654401
• Company Name: ADHERIUM (NZ) LIMITED
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	09421032180415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K221994

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2022-11-22
• Device Publish Date: 2022-11-14

On-Brand Devices [Hailie Sensor - for use only with Symbicort MDI]

• 94210321800589: Non-rechargeable battery
• 09421032180422: Inhaler dose sensor
• 09421032180415: Inhaler dose sensor
• 09421032180408: Inhaler dose sensor