Adult Nasal Cannula

GUDID 05055788782117

with Combined O2 Delivery / CO2 Monitoring and 2.1m Tubing

FLEXICARE MEDICAL LIMITED

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 05055788782117
• NIH Device Record Key: e06b38c3-7fe6-4c3d-ac0c-078b48972940
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Nasal Cannula
• Version Model Number: 032-10-189U
• 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	05055788782117 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140113

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 [Adult Nasal Cannula]

• 05055788782117: with Combined O2 Delivery / CO2 Monitoring and 2.1m Tubing
• 05055788758488: 032-10-020U