FreeStyle Comfort AS200-1R

GUDID M766AS2001R0

Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery

CAIRE INC.

Mobile/portable oxygen concentrator

• Primary Device ID: M766AS2001R0
• NIH Device Record Key: 34685ba6-cb16-4896-862c-55e4c366a5c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreeStyle Comfort
• Version Model Number: AS200-1R
• Catalog Number: AS200-1R
• Company DUNS: 807537683
• Company Name: CAIRE 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
HIBCC	M766AS2001R0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K020324

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: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [FreeStyle Comfort]

• M766AS2002010: Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English Two Single Batteries
• M766AS2001DTC0: Portable Oxygen Concentrator, 1-5 LPM, Pulse Dose Setting, English All Accessory Bag
• M766AS2001010: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Double Battery
• M766AS20010: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery
• M766AS2001R0: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery