Invacare® Platinum® Oxygen Concentrator IRC10LXO2

GUDID 00841447100041

INVACARE CORPORATION

Stationary oxygen concentrator

• Primary Device ID: 00841447100041
• NIH Device Record Key: 2df11014-5127-4ecd-90c1-832c7fe294d6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® Platinum® Oxygen Concentrator
• Version Model Number: IRC10LXO2
• Catalog Number: IRC10LXO2
• Company DUNS: 076916246
• Company Name: INVACARE CORPORATION
• 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: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com
• Phone: 440-329-6000
• Email: orders@invacare.com

Operating and Storage Conditions

• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Storage Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit
• Handling Environment Temperature: Between -20 Degrees Fahrenheit and 150 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447100041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020386

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: 2019-04-22
• Device Publish Date: 2015-09-14

On-Brand Devices [Invacare® Platinum® Oxygen Concentrator]

• 00841447100089: IRC10LX
• 00841447100041: IRC10LXO2
• 00841447100232: IRC5LXO2