Who else makes this device?

Name: Pro Nox
Brand: Pro Nox

Anesthesiology › TherapeuticMixer, Breathing Gases, Anesthesia Inhalation

Pro Nox

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.…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type

1catalogue number

2510(k) clearances naming this product code

1recall

Who Else Makes It

Concentrated in Guangdong (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code BZR
Manufacturer	City	Province	Registered as	Device types
Sunmed AP, Ltd.	Zhuhai	Guangdong	Contract manufacturer	18
Gentec (Shanghai) Corporation	Shanghai	Shanghai	Manufacturer	12

Record

Regulatory record for Pro Nox
Listed by	O-TWO Medical Technologies, Inc., Canada
FDA product code	BZR
Device type	Mixer, Breathing Gases, Anesthesia Inhalation
Device class	Class 2
Regulation	21 CFR 868.5330
Establishment	Specification developer, Repacker / relabeller, Manufacturer, Exporter
510(k)	K113687
Record published	2023-11-13

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Pro Nox
Catalogue number	Size	Status
CMI-0100-PNX		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Sechrist Industries, Inc.	Sechrist Industries, Inc.	43
Hyperinflation	Westmed, Inc.	21
Blender	Carefusion	19
Hyperinflation (Ambu)	Westmed, Inc.	19
MAXBLEND2	Maxtec, LLC	17
Blender	Vyaire Medical, Inc.	17
Ambu Hyperinflation System	Westmed, Inc.	12
Ambu	SunMed Group Holdings, LLC	12
MaxFlo2	Maxtec, LLC	11
MicroMax	Maxtec, LLC	9
Bird™	Vyaire Medical, Inc.	8
Gentec®	Gentec (Shanghai) Corporation	8

Showing 12 of 118. All products under Mixer, Breathing Gases, Anesthesia Inhalation

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K173205	2018-08-29
K113687	2012-04-30

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Pro Nox
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Carestream Health, Inc.	510(k) number	2018-05-15	Class II	Under Investigation by firm	Two analgesic gas delivery system oxygen/nitrous oxide mixers were reported to have delivered higher levels of nitrous oxide than specification during routine testing.	919 Units Total	2025-12-17
O-TWO Medical Technologies, Inc.	510(k) number	2018-05-14	Class II	Device Design	Higher levels of nitrous oxide delivered than specification	3 units	2020-06-03

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.