AccessGUDID - DEVICE: Pro Nox (17540195040073)

GUDID

Device Identifier (DI) Information

Brand Name: Pro Nox
Version or Model: CMI-0100-PNX
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: O-Two Medical Technologies Inc

Primary DI Number: 17540195040073
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 206449154 *Terms of Use

Device Description: The PRO NOX 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.

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 [?]
K113687	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b5e7705-0b07-4e2b-9a8f-a1682b3387d9
Public Version Date: November 21, 2023
Public Version Number: 1
DI Record Publish Date: November 13, 2023