ThermoShield Adult Bacterial Viral HMEF

GUDID 05055788772224

FLEXICARE MEDICAL LIMITED

Heat/moisture exchanger/microbial filter, sterile

• Primary Device ID: 05055788772224
• NIH Device Record Key: 4a9113fa-6288-403f-ad8a-b2e11426dacd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoShield Adult Bacterial Viral HMEF
• Version Model Number: 038-41-350STRU
• 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	05055788772224 [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: true

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 [ThermoShield Adult Bacterial Viral HMEF]

• 05055788772224: 038-41-350STRU
• 05055788770176: With Luer Port+Smoothbore Catheter Mount Swivel Elbow W/Cap
• 05055788770169: With Luer Port + Flexi-Lock Catheter Mount
• 05055788742470: 038-41-350U