Circulaire II Aerosol Drug Delivery System

GUDID 10709078000789

with Comfort Soft Plus adult non-vented mask, mouthpiece, B/V filter

WESTMED, INC.

Heat/moisture exchanger/microbial filter, non-sterile

• Primary Device ID: 10709078000789
• NIH Device Record Key: 8efff1f0-5ae6-40e7-85fc-6be0fa9eda0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire II Aerosol Drug Delivery System
• Version Model Number: 0330
• 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	00709078000782 [Primary]
GS1	10709078000789 [Package]; Contains: 00709078000782; Package: [25 Units]; In Commercial Distribution

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-12-11

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

• 10709078000796: w/ Comfort Soft Plus adult non-vented mask, MiniHeart Hi-Flo, and B/V filter
• 10709078000789: with Comfort Soft Plus adult non-vented mask, mouthpiece, B/V filter
• 10709078000734: With extra reservoir bag, with B/V filter, 7' tubing w/threaded nut
• 10709078000727: with extra reservoir bag, with B/V filter
• 00709078000706: with VixOne,, nose clip, mouthpiece, adult non-vented mask
• 10709078000697: with extra reservoir bag, violet