HELiOS 850

GUDID M766H850EU0

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

CAIRE INC.

Portable liquid oxygen unit

• Primary Device ID: M766H850EU0
• NIH Device Record Key: 5402ab0a-57de-42a2-8007-107054dc22eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELiOS 850
• Version Model Number: H850EU
• 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	M766H850EU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K993220

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: 2016-08-15

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