Dual Pediatric Mask

GUDID 05055788781714

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

FLEXICARE MEDICAL LIMITED

Rebreathing oxygen face mask

• Primary Device ID: 05055788781714
• NIH Device Record Key: e782d2a0-b68c-49b7-9e39-ee3f514d9fed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Pediatric Mask
• Version Model Number: 032-12-190U
• 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	05055788781714 [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 Pediatric Mask]

• 05055788781714: 7ft Combined O2 Delivery / CO2 Monitoring with Filter with Microstream Type Luer
• 05055788781691: 10ft Combined O2 Delivery / CO2 Monitoring. Filter with Microstream Type Luer