Invacare® Platinum® 10 Oxygen Concentrator IRC10LXO2AMZ

GUDID 00841447103370

Invacare IRC10LXO2 Platinum 10 Oxygen Concentrator

INVACARE CORPORATION

Mobile/portable oxygen concentrator

• Primary Device ID: 00841447103370
• NIH Device Record Key: 396ab189-3760-479b-bf8a-7624f34372ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Invacare® Platinum® 10 Oxygen Concentrator
• Version Model Number: IRC10LXO2AMZ
• Catalog Number: IRC10LXO2AMZ
• 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: false
• 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
• 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
• Phone: +1(440)329-6000
• Email: orders@invacare.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447103370 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-18
• Device Publish Date: 2024-04-10

Devices Manufactured by INVACARE CORPORATION

• 00841447111238 - microAIR: 2024-08-27 MICROAIR MA500 AP-LAL MATTRESS SYSTEM
• 00841447111245 - microAIR: 2024-08-27 MICROAIR MA600 AP-LAL MATTRESS SYSTEM
• 00841447111252 - microAIR: 2024-08-27 MICROAIR MA800 AP-LAL MATTRESS SYSTEM
• 00841447111290 - microAIR: 2024-08-27 MICROAIR MA900 LAT ROT LAL MATT SYS
• 05600494138705 - Invacare ISA Lift: 2024-08-27 INVACARE ISA XPLUS STAND-UP LIFT
• 05600494138712 - Invacare ISA Lift: 2024-08-27 INVACARE ISA COMPACT STAND-UP LIFT
• 00841447108757 - Invacare Deluxe 3 Position Medical Recliner Chair: 2024-08-23 3 POSITION RECLINER DLX-ADULT BLUE RDG
• 00841447108764 - Invacare Deluxe 3 Position Medical Recliner Chair: 2024-08-23 3 POSITION RECLINER-DELUXE ADULT JADE