Model: NFA4000
DI: 04260635790783
Status: New
MRI: MR Unsafe
Single-use: No
Rx: Yes
OTC: No
First Published: 2026-05-11
Current Version: 2026-05-19
Description
FlowStar Analog Mixer Flowmeter 70 %
Analog mixer flowmeter indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen (up to 70% N2O) to a conscious, spontaneously breathing patient for minimal sedation (anxiolysis) in medical and dental offices. Rx only.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
8b8045af-e596-449c-a97c-4630dd0334f6
Distribution Status:
In Commercial Distribution
DUNS Number:
343104962
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04260635790783
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 44159
Name: Oxygen/air/nitrous oxide breathing gas mixer
Definition:
An independent mechanical device designed for accurate mixing of oxygen (O2) and air or O2 and nitrous oxide (N2O) in pre-set concentrations appropriated for breathing. The mixer receives all three gases from either the hospital gas pipeline or from compressed gas cylinders; it may include a pressure-regulating mechanism. It usually delivers the gases with adjustable N2O or air concentrations and ensures a minimum O2 level to the patient through a face mask, mouthpiece, or endotracheal (ET) tube. It is used to improve O2 uptake and/or relieve pain throughout a hospital, during dental procedures, or in obstetrics during labour. It may also be attached to ventilators or anaesthesia machines.
FDA Product Codes
BZR
Mixer, Breathing Gases, Anesthesia Inhalation