FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit

GUDID 10709078004428

WESTMED, INC.

Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use Anaesthesia breathing circuit, single-use

• Primary Device ID: 10709078004428
• NIH Device Record Key: ca5b8998-87a5-4bda-b5b0-4cd3d47c7fbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit
• Version Model Number: 9572
• 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: true
• 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	00709078004421 [Primary]
GS1	10709078004428 [Package]; Contains: 00709078004421; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• OFP: Anesthesia Breathing Circuit Kit (Adult & Pediatric)

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-27
• Device Publish Date: 2017-09-13

On-Brand Devices [FloEasy Co-Flo, Disposable Heated Humidified Circuit Kit]

• 10709078004428: 9572
• 10709078004411: 9571