FDA.reportPublic FDA data

AirTechniques

Primary DI
04260635790790
Brand
AirTechniques
Company
Baldus Sedation GmbH & Co. KG
Model
NFT6500
Device description
FlowStar Touch Flex Digital Mixer Flowmeter with Bag TeeDigital 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.
Published
2026-05-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
BZRMixer, Breathing Gases, Anesthesia Inhalation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZRMixer, Breathing Gases, Anesthesia InhalationAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260635790790PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260635790790042606357907904260635790790

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen/air/nitrous oxide breathing gas mixerAn 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.

Regulatory Flags#

DUNS number
343104962
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260635790660AirTechniquesNFT60002026-05-11
04260635790776AirTechniquesNFA400052026-05-11
04260635790783AirTechniquesNFA40002026-05-11
04260635790431AirTechniquesNHA12BD2023-01-05
04260635790523AirTechniquesNHA12BB2023-01-05
04260635790547AirTechniquesNHA12HA2023-01-05
04260635790677AirTechniquesNHCO2-K2023-01-05
04260635790448AirTechniquesNHA12SD2023-01-05
04260635790479AirTechniquesNHP12BD2023-01-05
04260635790486AirTechniquesNHP12SD2023-01-05
04260635790530AirTechniquesNHP12BB2023-01-05
04260635790554AirTechiquesNHA12PG2023-01-05
04260635790578AirTechniquesNHP12CV2023-01-05
04260635790585AirTechniquesNHA12CV2023-01-05
04260635790592AirTechniquesNHP12HA2023-01-05
04260635790608AirTechniquesNHP12PG2023-01-05
04260635790103AirTechniquesNHAA1012022-12-02
04260635790158AirTechniquesNHAP1012022-12-02
04260635790493AirTechniquesNH-KIT2022-12-02
04260635790516AirTechniquesNSC-VCB2022-12-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260635790660AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790776AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
04260635790783AirTechniquesBaldus Sedation GmbH & Co. KGBZR2026-05-11
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