GUDID 00856702006020

Medication chamber of the Nebulizer

HEALTH & LIFE CO., LTD.

Ultrasonic nebulizing system

• Primary Device ID: 00856702006020
• NIH Device Record Key: cd5c2b8c-3497-4349-afee-343fedd6e20b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: MC-001
• Company DUNS: 657836743
• Company Name: HEALTH & LIFE CO., LTD.
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 700 Degrees Celsius and 1060 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856702006020 [Primary]
GS1	10856702006027 [Package]; Package: [120 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081738

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2018-07-06
• Device Publish Date: 2016-09-13

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