Invacare® Perfecto2™ Oxygen Concentrator IRC5P

GUDID 00841447100171

INVACARE CORPORATION

Stationary oxygen concentrator

• Primary Device ID: 00841447100171
• NIH Device Record Key: 3eef0e2b-b291-4429-af3f-5f58afe245ed
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® Perfecto2™ Oxygen Concentrator
• Version Model Number: IRC5P
• Catalog Number: IRC5P
• 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	00841447100171 [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® Perfecto2™ Oxygen Concentrator]

• 00841447100249: IRC5PO2W
• 00841447100218: IRC5PW
• 00841447100188: IRC5PO2VC
• 00841447100171: IRC5P
• 00841447100058: IRC5PO2
• 00841447100010: IRC5PO2V