FloEasy

GUDID 00709078013829

FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit

WESTMED, INC.

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• Primary Device ID: 00709078013829
• NIH Device Record Key: 32e4c781-fa51-42ad-8e1d-39cac6378809
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloEasy
• Version Model Number: 9570HTS
• Company DUNS: 092673953
• Company Name: WESTMED, INC.
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00709078013829 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

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: 2022-04-08
• Device Publish Date: 2022-03-31

On-Brand Devices [FloEasy ]

• 00709078013843: FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit
• 10709078013833: FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit
• 00709078013829: FloEasy CO-Flow, Disposable Heated Humidified Circuit Kit