AirTechniques

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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
4catalogue numbers in this listing
2510(k) clearances naming this product code

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 AirTechniques
Listed by Baldus Sedation GmbH & Co. KG, Germany
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
Record published 2026-05-11

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for AirTechniques
Catalogue number Size Status
NFA40005 In distribution
NFT6000 In distribution
NFA4000 In distribution
NFT6500 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
K230987 2023-09-14
K222794 2023-07-28

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer