Disposable Heated Humidified Circuit Kit

GUDID 10709078005111

FloEasy™ Co-Flo, Disposable Heated Humidified Circuit Kit

WESTMED, INC.

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• Primary Device ID: 10709078005111
• NIH Device Record Key: 176f1e65-8879-49d6-ba7b-bfa89c167579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Heated Humidified Circuit Kit
• Version Model Number: 9655
• 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	00709078005114 [Primary]
GS1	10709078005111 [Package]; Contains: 00709078005114; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K922492

FDA Product Code

• OGL: Oxygen Administration Kit

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: 2017-10-12

On-Brand Devices [Disposable Heated Humidified Circuit Kit]

• 00709078005374: 1- 0503-01 1- 9586
• 10709078005364: 1- 9586 1- 0562-01
• 10709078005111: FloEasy™ Co-Flo, Disposable Heated Humidified Circuit Kit