CAIRE Inc. AS200-SW41

GUDID M766AS200SW410

FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function, no accessories included device only.

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M766AS200SW410
• NIH Device Record Key: 0a1af3a8-e40c-418e-ac83-fe774a05de44
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAIRE Inc.
• Version Model Number: AS200-SW41
• Catalog Number: AS200-SW41
• Company DUNS: 807537683
• Company Name: CAIRE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit
• Handling Environment Temperature: Between 41 Degrees Fahrenheit and 104 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M766AS200SW410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250671

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: 2025-08-21
• Device Publish Date: 2025-08-13

On-Brand Devices [CAIRE Inc.]

• M766AS200SW410: FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function, no accessories included de
• M766AS200410: FreeStyle Comfort Portable Oxygen Concentrator with autoSAT function and single battery
• M766AS2002410: FreeStyle Comfort Oxygen Concentrator with autoSAT function, 2 single batteries
• M766AS2001410: FreeStyle Comfort Oxygen Concentrator with autoSAT function, double battery