Circulaire II Aerosol Drug Delivery System

GUDID 10709078000697

with extra reservoir bag, violet

WESTMED, INC.

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• Primary Device ID: 10709078000697
• NIH Device Record Key: c5b30dfc-8241-4f9a-8fcb-49b9b56ec357
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire II Aerosol Drug Delivery System
• Version Model Number: 0295
• 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	00709078000690 [Primary]
GS1	10709078000697 [Package]; Contains: 00709078000690; Package: [25 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926055

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

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: 2016-12-10

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