VisionAire

GUDID M766AS0987190

VISIONAIRE OXYGEN CONCENTRATOR, 5 LPM

CAIRE INC.

Stationary oxygen concentrator

• Primary Device ID: M766AS0987190
• NIH Device Record Key: 077d5021-3899-4474-a0f0-694025d02ef9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VisionAire
• Version Model Number: AS098-719
• 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	M766AS0987190 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872534

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: 2020-08-14
• Device Publish Date: 2020-08-06

Devices Manufactured by CAIRE INC.

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• M766AS2001R0 - FreeStyle Comfort: 2024-08-19 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English Single Battery
• M766AS2001060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Double Battery
• M766AS2002060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Two Single Batteries
• M766AS20060 - Arya: 2021-11-16 Portable Oxygen Concentrator 1-5 LPM, Pulse Dose Settings, English, Single Battery
• M76613256929SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613256961SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner