Maxineb Duo Nebulizer + Mouthpiece And Filter

GUDID 05055931102014

FLEXICARE MEDICAL LIMITED

Nebulizing system, non-heated

• Primary Device ID: 05055931102014
• NIH Device Record Key: fd0fd87d-47f1-473e-8ac6-d7c32792b17d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Maxineb Duo Nebulizer + Mouthpiece And Filter
• Version Model Number: 032-10-034U
• Company DUNS: 504406273
• Company Name: FLEXICARE MEDICAL 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055931102014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102719

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: 2020-04-06
• Device Publish Date: 2020-03-27

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