Equinox Relieve

FDA UDI

Class II (US FDA UDI)

by O-Two Medical Technologies Inc

Identity

Trade Name: Equinox Relieve FDA UDI
Generic Name: Inhalational analgesia unit FDA UDI
Device Name: 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 only one 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. FDA UDI
Model / Reference: 01EQ1000 FDA UDI
Description: 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 only one 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. FDA UDI

Identifiers

Catalog Number: 01EQ1000 FDA UDI
Primary DI / UDI-DI: 07540195040021 FDA UDI
510(k) Number: K113687 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size: Weight — 1.5 Kilogram FDA UDI
Height — 3.9 Inch FDA UDI
Width — 6.6 Inch FDA UDI
Length — 8.9 Inch FDA UDI

Category: Inhalational analgesia unit

Equinox Relieve 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.

NITRONOX PLUS — Parker Hannifin Corp. · Class II
NITRONOX FIELD INHALATION ANALGESIA MACHINE — Parker Hannifin Corp. · Class II
NOX HD-NS 2 CYLINDER CART — Parker Hannifin Corp. · Class II
NITRONOX PLUS — Parker Hannifin Corp. · Class II
NITRONOX INHALATION HOSPITAL MIXER ANALGESIA MACHINE — Parker Hannifin Corp. · Class II
NITRONOX INHALATION HOSPITAL MIXER ANALGESIA MACHINE — Parker Hannifin Corp. · Class II
AincA® — Anesthesia Associates, Inc. · Class II
NITRONOX PLUS — Parker Hannifin Corp. · Class II

Cleared under the same submission

K113687 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: O-Two Medical Technologies Inc

Sources (1)

FDA UDI f5a1e7e7-9708-424b-80f6-95b0a0c075fb 38 fields · synced May 30, 2026