Dual Adult Mask

GUDID 05055788781912

7ft Combined O2 Delivery/CO2 Monitoring Nose Clip Filter with Microstream Type Luer

FLEXICARE MEDICAL LIMITED

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• Primary Device ID: 05055788781912
• NIH Device Record Key: dcecea2b-40a8-4c0f-a99c-5e12db11a706
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Adult Mask
• Version Model Number: 032-10-190U
• 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	05055788781912 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133516

FDA Product Code

• CCK: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

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: 2019-01-11
• Device Publish Date: 2018-12-11

On-Brand Devices [Dual Adult Mask]

• 05055788781912: 7ft Combined O2 Delivery/CO2 Monitoring Nose Clip Filter with Microstream Type Luer
• 05055788781899: 10ft Combined O2 Delivery/CO2 Monitoring Nose Clip Filter with Microstream Type Luer