Invacare® Platinum™ Mobile Oxygen Concentractor

GUDID 00841447102915

Platinum Mobile Oxygen Concentrator P5

INVACARE CORPORATION

Portable oxygen concentrator

• Primary Device ID: 00841447102915
• NIH Device Record Key: 814f96c6-0f6b-4f14-bb6e-de61e1e74667
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® Platinum™ Mobile Oxygen Concentractor
• Version Model Number: POC1-100C
• 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: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com
• Phone: +1(440)329-6000
• Email: orders@invacare.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 15 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -25 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447102915 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160630

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: 2
• Public Version Date: 2019-04-22
• Device Publish Date: 2018-11-27

On-Brand Devices [Invacare® Platinum™ Mobile Oxygen Concentractor]

• 00841447102939: Platinum Mobile Oxygen Concentrator P5 - User
• 00841447102915: Platinum Mobile Oxygen Concentrator P5