Adult Circ Sing Lmb HTD/W (22mm Shielded Tube) & AutoFCh

GUDID 05055788709664

FLEXICARE MEDICAL LIMITED

Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier Heated respiratory humidifier

• Primary Device ID: 05055788709664
• NIH Device Record Key: 11e31024-c287-4995-b54c-5e04de3bb77a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adult Circ Sing Lmb HTD/W (22mm Shielded Tube) & AutoFCh
• Version Model Number: 038-35-963U
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055788709664 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150900

FDA Product Code

• BZE: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2016-10-04

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