HELiOS 46

GUDID M766B701652000

Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI

CAIRE INC.

Stationary liquid oxygen container

• Primary Device ID: M766B701652000
• NIH Device Record Key: a751e6f3-cb95-4cfa-9a65-72cc13a0fdfb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HELiOS 46
• Version Model Number: B-701652-00
• 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	M766B701652000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K860937

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

On-Brand Devices [HELiOS 46]

• M766B702099000: Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI
• M766B701652000: Base Liquid Oxygen Respiratory Equipment, Top Fill, 10 LPM, 20 PSI