Dual Nasal Cannula Neonatal 2.1m Combined O2 Deliv

GUDID 05055788754718

FLEXICARE MEDICAL LIMITED

Carbon-dioxide-sampling nasal oxygen cannula

• Primary Device ID: 05055788754718
• NIH Device Record Key: a56ab3d4-658e-4d1c-9117-85ecbdc80bc7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Dual Nasal Cannula Neonatal 2.1m Combined O2 Deliv
• Version Model Number: 032-13-125U
• 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	05055788754718 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-02-12

On-Brand Devices [Dual Nasal Cannula Neonatal 2.1m Combined O2 Deliv]

• 05055788754718: 032-13-125U
• 05055788754688: Female Luer