ThermoShield Neonatal Bacterial Viral Filter and H

GUDID 05055788770244

FLEXICARE MEDICAL LIMITED

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 05055788770244
• NIH Device Record Key: 75c3a129-2b40-4ff1-ac81-6597abd4d971
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoShield Neonatal Bacterial Viral Filter and H
• Version Model Number: 038-43-355U
• 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	05055788770244 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163300

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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

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