Companion 31

GUDID M766B775920000

Base Liquid Oxygen Respiratory Equipment, Top Fill, 6 LPM, 20 PSI

CAIRE INC.

Stationary liquid oxygen container

• Primary Device ID: M766B775920000
• NIH Device Record Key: 5cc1dcaf-4e2b-45e4-91ea-f1570a482193
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Companion 31
• Version Model Number: B-775920-00
• 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	M766B775920000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K830498

FDA Product Code

• BYJ: Unit, Liquid-Oxygen, Portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-08-24

Devices Manufactured by CAIRE INC.

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• 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