AIR 11

Basic Information

• Brand Name: AIR 11
• Primary DI: 00619498393053
• Version / Model: 39305
• Catalog Number: 39305
• Company Name: RESMED PTY LTD
• Labeler DUNS: 751149311
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-25
• Public Version: 3
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: be9d7499-5349-443c-87e5-935fbfde7f76

Device Description

AIR11 FILTER, HYPO, 2 PACK

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: No
• 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
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	868.5905	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37597	Heat/moisture exchanger insertable filter	A dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00619498393053	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -13 – 158 Degrees Fahrenheit