Airsep Corp. AS074-4

GUDID M638AS07440

AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow

AIRSEP CORPORATION

Stationary oxygen concentrator

• Primary Device ID: M638AS07440
• NIH Device Record Key: a26d8742-770f-4d82-99f4-c78d951246f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Airsep Corp.
• Version Model Number: Centrox
• Catalog Number: AS074-4
• Company DUNS: 834499415
• Company Name: AIRSEP 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: 716-691-0202
• Email: info@airsep.com
• Phone: 716-691-0202
• Email: info@airsep.com
• Phone: 716-691-0202
• Email: info@airsep.com
• Phone: 716-691-0202
• Email: info@airsep.com
• Phone: 716-691-0202
• Email: info@airsep.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M638AS07440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101154

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: 2025-03-10
• Device Publish Date: 2025-02-28

Devices Manufactured by AIRSEP CORPORATION

• M638AS07440 - Airsep Corp.: 2025-03-10AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow
• M638AS07440 - Airsep Corp.: 2025-03-10 AirSep Centrox Oxygen Concentrator. 15 LPM Max continuous flow
• M638AS07710 - FreeStyle 5: 2020-04-20 Portable Oxygen Concentrator, 1-5 LPM equivalent
• M638AS0771CU0 - FreeStyle 5: 2020-04-20 Portable Oxygen Concentrator, 1-5 LPM, Re-manufactured, complete unit.
• M638AS0771U0 - FREESTYLE 5: 2020-04-20 PORTABLE OXYGEN CONCENTRATOR, 1-5 LPM, PULSE DOSE, REMANUFACTURED
• M638AS07810 - Focus: 2020-04-20 Portable Oxygen Concentrator, 2 LPM equivalent
• M638AS0781CU0 - Focus: 2020-04-20 Portable Oxygen Concentrator, 2 LPM, Re-manufactured, complete unit
• M638AS0781U0 - Focus: 2020-04-20 Portable oxygen concentrator, 2 lpm pulse dose flow, remanufactured
• M638AS09510 - FreeStyle: 2020-04-20 Portable Oxygen Concentrator, 1 - 3 LPM Equivalent