Device
FlowStar Touch Flex Digital Mixer Flowmeter with Bag Tee
Manufacturer
Baldus Sedation GmbH & Co. KG
Model: NFT6500 DI: 04260635790790 Status: New MRI: MR Unsafe Single-use: No Rx: Yes OTC: No
First Published: 2026-05-11 Current Version: 2026-05-19
Description
FlowStar Touch Flex Digital Mixer Flowmeter with Bag Tee Digital flex mixer flowmeter indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen 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: a6bf7674-cd64-4f6f-9cc8-c720303360db
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: 04260635790790
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