Identity
- Trade Name
- Pro Nox FDA UDI
- Generic Name
- Inhalational analgesia unit FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- CMI-0100-PNX FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540195040073 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
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Inhalational analgesia unit
Pro Nox 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 6b5e7705-0b07-4e2b-9a8f-a1682b3387d9 35 fields · synced May 30, 2026