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 a 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: 01EQ1000F 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 a 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: 01EQ1000F FDA UDI
Primary DI / UDI-DI: 07540195040045 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: Length — 8.9 Inch FDA UDI
Width — 6.6 Inch FDA UDI
Height — 3.9 Inch FDA UDI
Weight — 1.5 Kilogram 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 36fa79f6-3d97-41f3-98a2-6c9b6a7bd988 38 fields · synced Jun 1, 2026