Circulaire

GUDID 10709078009140

Circulaire Aerosol Masks

WESTMED, INC.

Tracheostomy mask, aerosol

• Primary Device ID: 10709078009140
• NIH Device Record Key: b6f1b5a0-6513-4060-b434-eb7cd15ea57b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Circulaire
• Version Model Number: 0296
• 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	00709078009143 [Primary]
GS1	10709078009140 [Package]; Contains: 00709078009143; Package: [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K926055

FDA Product Code

• BYG: Mask, Oxygen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-08
• Device Publish Date: 2020-08-31

On-Brand Devices [Circulaire]

• 10709078009140: Circulaire Aerosol Masks
• 10709078009133: Circulaire Aerosol Masks