Co-Flo Heated Humidified Circuit

GUDID 00709078004452

WESTMED, INC.

Airway temperature monitoring system

• Primary Device ID: 00709078004452
• NIH Device Record Key: 7312ddcd-d8d7-43f7-87ce-996b655de201
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Co-Flo Heated Humidified Circuit
• Version Model Number: 9586
• 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	00709078004452 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K870173

FDA Product Code

• CAH: Filter, Bacterial, Breathing-Circuit

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-27

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