Arya

GUDID M766AS2002060

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

CAIRE INC.

Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator Mobile/portable oxygen concentrator

• Primary Device ID: M766AS2002060
• NIH Device Record Key: 558ab5c3-e061-4b7b-841f-7694b497e067
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Arya
• Version Model Number: AS200-206
• 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	M766AS2002060 [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: 2021-11-16
• Device Publish Date: 2021-11-08

On-Brand Devices [Arya]

• M766AS20060: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery
• M766AS2002060: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Two Single Batteries
• M766AS2001060: Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Double Battery