Neonatal Single Limb Heated Wire Breathing System HFOT 1.6 Kit 1

GUDID 05055788771081

FLEXICARE MEDICAL LIMITED

Ventilator breathing circuit, single-use

• Primary Device ID: 05055788771081
• NIH Device Record Key: 18f88e6b-7dcd-453e-9f76-b5f4758cd78f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neonatal Single Limb Heated Wire Breathing System HFOT 1.6 Kit 1
• Version Model Number: 038-33-402U
• 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	05055788771081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160540

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2018-02-12

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