Platinum® 10L Oxygen Concentrator IRC10LXO2

GUDID 00850018761321

VENTEC LIFE SYSTEMS, INC.

Stationary oxygen concentrator

• Primary Device ID: 00850018761321
• NIH Device Record Key: e3bfaa61-2a17-4742-be3f-02f12b874567
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Platinum® 10L Oxygen Concentrator
• Version Model Number: IRC10LXO2
• Catalog Number: IRC10LXO2
• Company DUNS: 078758082
• Company Name: VENTEC LIFE SYSTEMS, INC.
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841447100041 [Previous]
GS1	00850018761321 [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: 2024-12-30
• Device Publish Date: 2024-12-20

Devices Manufactured by VENTEC LIFE SYSTEMS, INC.

• 00850018761321 - Platinum® 10L Oxygen Concentrator: 2024-12-30
• 00850018761321 - Platinum® 10L Oxygen Concentrator: 2024-12-30
• 00850018761383 - VOCSN Passive Valve: 2024-12-10
• 00850018761307 - HomeFill® Oxygen System: 2023-10-24
• 00850018761352 - HomeFill® Oxygen System: 2023-10-24
• 00850018761369 - HomeFill® Oxygen System: 2023-10-24
• 00850018761376 - HomeFill® Oxygen System: 2023-10-24
• 00855573007822 - VOCSN: 2023-07-10
• 00850018761291 - PreciseRx™ Pediatric Flowmeter: 2023-06-26