FL9000

GUDID 05055931111009

Respiratory Humidifier Single Use Temperature Probe

FLEXICARE MEDICAL LIMITED

Heated respiratory humidifier

• Primary Device ID: 05055931111009
• NIH Device Record Key: 753e27de-6b77-473b-bd0b-b3741d2b6ec8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FL9000
• Version Model Number: FL9000-04U
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055931111009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161314

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: 2024-03-22
• Device Publish Date: 2024-03-14

On-Brand Devices [FL9000]

• 05055931112983: Respiratory Humidifier Single Use Temperature Probe (Sterile)
• 05055931111009: Respiratory Humidifier Single Use Temperature Probe