Equinox Advantage
The Equinox Advantage mixes nitrous oxide and oxygen to provide on-demand analgesia to conscious patients who breathe spontaneously. The portable, pneumatically powered device connects to…
The Equinox Advantage mixes nitrous oxide and oxygen to provide on-demand analgesia to conscious patients who breathe spontaneously. The portable, pneumatically powered device connects to separate gas cylinders through pressure regulators.
When the device is on, the patient’s inspiratory effort triggers gas delivery. A selector adjusts oxygen from 25 to 100 percent, with nitrous oxide making up the remainder. A separate oxygen-enrichment function supplies pure oxygen to flush residual gas after treatment.
Listed Item
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.
Gas Supply Alarms
Visual and audible alarms indicate low inlet pressure for either gas. Oxygen supply falling below the shutdown threshold stops operation, helping prevent continued delivery without an adequate oxygen source.
Who Else Makes It
Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Gentec (Shanghai) Corporation | Shanghai | Shanghai | Manufacturer | 12 |
Record
| Listed by | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BZR |
| Device type | Mixer, Breathing Gases, Anesthesia Inhalation |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5330 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K173205 |
| Record published | 2018-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 60 °C |
| Sizes | Weight 2 kg; height 4.4 in; width 7.6 in; length 9.3 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01EQ2000 | Weight 2.0 kg | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sechrist Industries, Inc. | Sechrist Industries, Inc. | 43 |
| Hyperinflation | Westmed, Inc. | 21 |
| Blender | Carefusion | 19 |
| Hyperinflation (Ambu) | Westmed, Inc. | 19 |
| MAXBLEND2 | Maxtec, LLC | 17 |
| Blender | Vyaire Medical, Inc. | 17 |
| Ambu Hyperinflation System | Westmed, Inc. | 12 |
| Ambu | SunMed Group Holdings, LLC | 12 |
| MaxFlo2 | Maxtec, LLC | 11 |
| MicroMax | Maxtec, LLC | 9 |
| Bird™ | Vyaire Medical, Inc. | 8 |
| Gentec® | Gentec (Shanghai) Corporation | 8 |
Showing 12 of 118. All products under Mixer, Breathing Gases, Anesthesia Inhalation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173205 | 2018-08-29 |
| K113687 | 2012-04-30 |
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-05-14 | Class II | Device Design | Higher levels of nitrous oxide delivered than specification | 3 units | 2020-06-03 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.