Hygrovent Gold Comfort

GUDID 05055788793786

FLEXICARE MEDICAL LIMITED

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 05055788793786
• NIH Device Record Key: a2970335-ec9e-4f29-90b8-03b3ed2b3705
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hygrovent Gold Comfort
• Version Model Number: 356-001-010U
• Company DUNS: 504406273
• Company Name: FLEXICARE MEDICAL LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055788793786 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-10-31

On-Brand Devices [Hygrovent Gold Comfort]

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