Equinox Advantage
O-Two Medical Technologies Inc · Model 01EQ2000 · UDI-DI 07540195040069
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.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-05-15 | CAREstream Medical LLC | Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing. |
| 2018-05-14 | O-Two Medical Technologies, Inc. | Higher levels of nitrous oxide delivered than specification |
| 2005-01-11 | Maquet Inc | Software update so US customers will be updated equally with worldwide customers. Ver. 5.0 will be upgraded to ver 7.0. Quality will improve and enhance functionality. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docs