Equinox Relieve 01EQ1000

GUDID 07540195040014

The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable pneumatically powered device designed to provide a 50/

O-Two Medical Technologies Inc

Inhalational analgesia unit
Primary Device ID07540195040014
NIH Device Record Keyf5a1e7e7-9708-424b-80f6-95b0a0c075fb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEquinox Relieve
Version Model Number01EQ1000
Catalog Number01EQ1000
Company DUNS206449154
Company NameO-Two Medical Technologies Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-387-3405
Emailcs@otwo.com

Device Dimensions

Weight1.5 Kilogram
Height3.9 Inch
Width6.6 Inch
Length8.9 Inch

Operating and Storage Conditions

Storage Environment TemperatureBetween -40 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS107540195040014 [Direct Marking]
GS107540195040021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BZRMixer, Breathing Gases, Anesthesia Inhalation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-26
Device Publish Date2018-10-25

On-Brand Devices [Equinox Relieve]

07540195040014The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable
07540195040045The Equinox Relieve Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System is a portable

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