Circulaire

Basic Information

• Brand Name: Circulaire
• Primary DI: 00709078009143
• Version / Model: 0296
• Company Name: WESTMED, INC.
• Labeler DUNS: 092673953
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 3
• Public Version Date: 2024-02-29
• Public Version Status: Update
• Public Device Record Key: b6f1b5a0-6513-4060-b434-eb7cd15ea57b
• Distribution End Date: 2024-02-29

Device Description

Circulaire Aerosol Masks

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BYG	Mask, Oxygen	Anesthesiology	868.5580	1
CAF	Nebulizer (Direct Patient Interface)	Anesthesiology	868.5630	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35179	Tracheostomy mask, aerosol	A device designed to deliver air, oxygen, or a mixture of the two gases with aerosolized water particles to a patient who has a tracheostomy airway. It is typically connected to an oxygen source and nebulizer with wide bore tubing and is constructed of plastic. The device can be used over a tracheostomy tube or a stoma and is secured with a strap. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10709078009140	GS1		50	Not in Commercial Distribution	2024-02-29
Primary	00709078009143	GS1

Premarket Submissions

Submission Number	Supplement Number
K926055	000