AccessGUDID - DEVICE: Equinox Advantage (07540195040069)

GUDID

Device Identifier (DI) Information

Brand Name: Equinox Advantage
Version or Model: 01EQ2000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 01EQ2000
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 07540195040069
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
16953	Inhalational analgesia unit	A device primarily designed to administer analgesic gases to the patient, or produce analgesic vapours for inhalation. The unit will typically include a demand valve; some may be connected to a vaporizer calibrated for the administration of analgesic concentrations of inhalational anaesthetic agents. Typically used: 1) during labour to help the patient retain her consciousness while pain sensations are subdued; or 2) in dentistry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BZR	Mixer, Breathing Gases, Anesthesia Inhalation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K173205	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -40 and 60 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 2.0 Kilogram
Height: 4.4 Inch
Width: 7.6 Inch
Length: 9.3 Inch

Device Record Status

Public Device Record Key: d70d3ecd-3333-4e1b-b58a-d1f524040918
Public Version Date: November 30, 2018
Public Version Number: 1
DI Record Publish Date: October 30, 2018