iGo2

GUDID 00885304022237

Portable oxygen concentrator

DEVILBISS HEALTHCARE LLC

Portable oxygen concentrator

• Primary Device ID: 00885304022237
• NIH Device Record Key: ab6a5a46-4a47-4af1-8890-9847025e581d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: iGo2
• Version Model Number: 125D
• 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
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com
• Phone: 800-338-1988
• Email: somdhccustomerservice@devilbisshc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 0 Degrees Celsius
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885304022237 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172648

FDA Product Code

• CAW: Generator, Oxygen, Portable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-09
• Device Publish Date: 2019-05-01

On-Brand Devices [iGo2]

• 00885304032250: Portable oxygen concentrator, with extra battery
• 00885304022251: Portable oxygen concentrator
• 00885304022244: Portable oxygen concentrator
• 00885304022237: Portable oxygen concentrator