DeVilbiss iFill

Basic Information

• Brand Name: DeVilbiss iFill
• Primary DI: 00885304000853
• Version / Model: 535D
• Catalog Number: 535D
• Company Name: DEVILBISS HEALTHCARE LLC
• Labeler DUNS: 962175894
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-11-06
• Public Version: 4
• Public Version Date: 2018-08-23
• Public Version Status: Update
• Public Device Record Key: 371af944-ad51-4553-823c-cbfed48fa958

Device Description

Portable Oxygen Station

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: Yes
• Has Lot/Batch Number: No
• 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
CAW	Generator, Oxygen, Portable	Anesthesiology	868.5440	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61605	Oxygen compressor, home-use	A mains electricity (AC-powered) electromechanical device intended to be used in conjunction with a stationary oxygen concentrator to pressurize and fill/refill ambulatory oxygen cylinders with medical oxygen (O2). It is operated by the patient in the home to facilitate mobile oxygen therapy.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885304000853	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K053240	000

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 95 Percent (%) Relative Humidity
• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius