VisionAire

GUDID M766AS0987190

VISIONAIRE OXYGEN CONCENTRATOR, 5 LPM

CAIRE INC.

Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator Stationary oxygen concentrator 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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• 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
• M76613256996SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613258385SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner
• M76613258406SM0 - Liberator: 2020-08-14 Base Liquid Oxygen Respiratory Equipment, Dual Fill, 15 LPM, 20 PSI, Short Inner