Circulaire II Hybrid Aerosol Drug Delivery System

GUDID 10709078000864

With VixOne, Mouthpiece, Filter

WESTMED, INC.

Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial filter, non-sterile Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter Heat/moisture exchanger/microbial medical gas filter

• Primary Device ID: 10709078000864
• NIH Device Record Key: f39c415d-7ece-483e-838e-be2b016d4ceb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire II Hybrid Aerosol Drug Delivery System
• Version Model Number: 0396
• 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	00709078000867 [Primary]
GS1	10709078000864 [Package]; Contains: 00709078000867; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926055

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: 2016-12-11

On-Brand Devices [Circulaire II Hybrid Aerosol Drug Delivery System]

• 10709078000864: With VixOne, Mouthpiece, Filter
• 10709078000833: Reusable VixOne, Mouthpiece, Filter
• 10709078000819: with reusable VixOne, Mouthpiece