Equinox Relieve 01EQ1000F

GUDID 07540195040045

The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/50% nitrous oxide and oxygen mixture. It provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be activated by an inspiratory effort by the patient. The out put of N2O/O2 gas mixture is pre-set at 50/50%. Neither the patient nor medical personnel are able to adjust, eliminating the risk of delivering a hypoxic mixture.

O-Two Medical Technologies Inc

Inhalational analgesia unit

• Primary Device ID: 07540195040045
• NIH Device Record Key: 36fa79f6-3d97-41f3-98a2-6c9b6a7bd988
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Equinox Relieve
• Version Model Number: 01EQ1000F
• Catalog Number: 01EQ1000F
• Company DUNS: 206449154
• Company Name: O-Two Medical Technologies 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

Customer Support Contacts

• Phone: 1-800-387-3405
• Email: cs@otwo.com

Device Dimensions

• Weight: 1.5 Kilogram

Operating and Storage Conditions

• Storage Environment Temperature: Between -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540195040038 [Direct Marking]
GS1	07540195040045 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113687

FDA Product Code

• BZR: Mixer, Breathing Gases, Anesthesia Inhalation

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: 2019-05-13
• Device Publish Date: 2019-05-03

On-Brand Devices [Equinox Relieve]

• 07540195040014: The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable
• 07540195040045: The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable