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Equinox Advantage

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name
Equinox Advantage FDA UDI
Generic Name
Inhalational analgesia unit FDA UDI
Device Name
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. FDA UDI
Model / Reference
01EQ2000 FDA UDI
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. FDA UDI

Identifiers

Catalog Number
01EQ2000 FDA UDI
Primary DI / UDI-DI
07540195040069 FDA UDI
510(k) Number
K173205 FDA UDI
FDA Product Code
BZR FDA UDI
GMDN Term
Inhalational analgesia unit FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5330 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 2.0 Kilogram FDA UDI
Height — 4.4 Inch FDA UDI
Width — 7.6 Inch FDA UDI
Length — 9.3 Inch FDA UDI

Category: Inhalational analgesia unit

Equinox Advantage by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Inhalational analgesia unit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
O-Two Medical Technologies Inc

Sources (1)

  • FDA UDI d70d3ecd-3333-4e1b-b58a-d1f524040918 38 fields · synced May 30, 2026