Focus

GUDID M638AS07810

Portable Oxygen Concentrator, 2 LPM equivalent

AIRSEP CORPORATION

Mobile/portable oxygen concentrator

• Primary Device ID: M638AS07810
• NIH Device Record Key: 39f8559e-d8c2-439b-8c4f-ec67e7a28d20
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Focus
• Version Model Number: AS078-1
• 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	M638AS07810 [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 [Focus]

• M638AS0781U0: Portable oxygen concentrator, 2 lpm pulse dose flow, remanufactured
• M638AS0781CU0: Portable Oxygen Concentrator, 2 LPM, Re-manufactured, complete unit
• M638AS07810: Portable Oxygen Concentrator, 2 LPM equivalent