DeVilbiss iFill 535D

GUDID 00885304000853

Portable Oxygen Station

DEVILBISS HEALTHCARE LLC

Oxygen compressor, home-use Oxygen compressor, home-use

• Primary Device ID: 00885304000853
• NIH Device Record Key: 371af944-ad51-4553-823c-cbfed48fa958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeVilbiss iFill
• Version Model Number: 535D
• Catalog Number: 535D
• Company DUNS: 962175894
• Company Name: DEVILBISS HEALTHCARE LLC
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885304000853 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053240

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-23
• Device Publish Date: 2015-11-06

On-Brand Devices [DeVilbiss iFill]

• 00885304000860: Portable Oxygen Station
• 00885304000853: Portable Oxygen Station