Hygrovent Gold Comfort

GUDID 05055788778486

FLEXICARE MEDICAL LIMITED

Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 05055788778486
• NIH Device Record Key: 5536d49c-48a4-42f9-a4e9-e45019dfedb9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hygrovent Gold Comfort
• Version Model Number: 356-001-010B
• 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	05055788778486 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052615

FDA Product Code

• BTT: Humidifier, Respiratory Gas, (Direct Patient Interface)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-12-22
• Device Publish Date: 2020-03-25

On-Brand Devices [Hygrovent Gold Comfort]

• 05055788792291: 356-000-010U
• 05055788793786: 356-001-010U
• 05055788778486: 356-001-010B