SureFlow

GUDID M766FM06910

1 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an accessory to the NewLife Intensity Concentrator or other oxygen source (not to exceed 50 psi) where there is a need to split the product flow to the concentrator to supply up to 5 different users.

CAIRE INC.

Medical gas flowmeter, Thorpe tube

• Primary Device ID: M766FM06910
• NIH Device Record Key: 082758f4-a19b-4f49-9a19-a88dc0fbad61
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SureFlow
• Version Model Number: FM069-1
• Company DUNS: 807537683
• Company Name: CAIRE INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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	M766FM06910 [Primary]

FDA Product Code

• BXY: Flowmeter, Calibration, Gas

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-02-27

On-Brand Devices [SureFlow]

• M766FM06920: 2 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an
• M766FM06910: 1 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an
• M766FM06950: 5 LPM Oxygen Therapy Flowmeter cabinet that houses five independent flow meters to be used as an