Equinox Advantage

Basic Information

• Brand Name: Equinox Advantage
• Primary DI: 07540195040069
• Version / Model: 01EQ2000
• Catalog Number: 01EQ2000
• Company Name: O-Two Medical Technologies Inc
• Labeler DUNS: 206449154
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-30
• Public Version: 1
• Public Version Date: 2018-11-30
• Public Version Status: New
• Public Device Record Key: d70d3ecd-3333-4e1b-b58a-d1f524040918

Device Description

The Equinox Advantage Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device intended to administer an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to provide pain relief, on demand, to a conscious, spontaneously breathing, patient. The device provides two input connectors for connection with nitrous oxide and oxygen cylinders through pressure regulators. The device has a control knob for turning ON or OFF the device. When it is turned ON, the output of N2O/O2 gas mixture will only be administered by an inspiratory effort by the patient. The output ratio adjustable knob controls the percentage of the out analgesic gas mixture. The adjustable range is from 25% O2 (N2O 75%) to 100% O2 (N2O 0%). The minimum of 25% oxygen output eliminates delivering a hypoxic mixture. The oxygen enrichment button allows 100% oxygen supply in case of emergency.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BZR	Mixer, Breathing Gases, Anesthesia Inhalation	Anesthesiology	868.5330	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16953	Inhalational analgesia unit	A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. The unit will typically include a demand valve; some may be connected to a vaporizer calibrated for the administration of analgesic concentrations of inhalational anaesthetic agents. Typically used: 1) during labour to help the patient retain her consciousness while pain sensations are subdued; or 2) in dentistry.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Direct Marking	07540195040052	GS1
Primary	07540195040069	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K173205	000

Device Sizes

Type	Value	Unit	Text
Weight	2.0	Kilogram
Height	4.4	Inch
Width	7.6	Inch
Length	9.3	Inch

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 60 Degrees Celsius