FreeStyle

GUDID M638AS09510

Portable Oxygen Concentrator, 1 - 3 LPM Equivalent

AIRSEP CORPORATION

Mobile/portable oxygen concentrator

• Primary Device ID: M638AS09510
• NIH Device Record Key: c54959f5-32dd-4763-be5e-fc183e55c28e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle
• Version Model Number: AS095-1
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M638AS09510 [Primary]

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: 3
• Public Version Date: 2020-04-20
• Device Publish Date: 2015-06-15

On-Brand Devices [FreeStyle]

• M638AS0951U0: Portable oxygen concentrator, 1-3 LPM pulse dose delivery, remanufactured
• M638AS0951CU0: Portable Oxygen Concentrator, 1-3 LPM, Re-manufactured, complete unit.
• M638AS09510: Portable Oxygen Concentrator, 1 - 3 LPM Equivalent