Aerosure

Basic Information

• Brand Name: Aerosure
• Primary DI: 00858058005047
• Version / Model: 3481AJ
• Catalog Number: 1474
• Company Name: ACTEGY LIMITED
• Labeler DUNS: 735575941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-05-04
• Public Version: 1
• Public Version Date: 2021-05-12
• Public Version Status: New
• Public Device Record Key: 046b462f-0cbb-49c6-a429-c8a44daaffdf

Device Characteristics

• Single Use: No
• 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: Yes
• 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
BWF	Spirometer, Therapeutic (Incentive)	Anesthesiology	868.5690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
43017	Respiratory muscle training mask	A mask placed over the nose/mouth designed to create resistance for a patient's airway while inhaling and/or exhaling during respirations to strengthen and rehabilitate the respiratory muscles. It typically creates resistance through a mechanical means (e.g., a spring-loaded valve) that can be adjusted to provide progressive training. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10858058005044	GS1	Outer carton	10	In Commercial Distribution
Primary	00858058005047	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K140772	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: .4 – 122 Degrees Fahrenheit
• Type: Storage Environment Humidity
• Temperature Range: 25 – 85 Percent (%) Relative Humidity