AirTechniques

Basic Information

• Brand Name: AirTechniques
• Primary DI: 04260635790684
• Version / Model: NSP0020
• Company Name: Baldus Sedation GmbH & Co. KG
• Labeler DUNS: 343104962
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-02
• Public Version: 1
• Public Version Date: 2022-12-12
• Public Version Status: New
• Public Device Record Key: 8b9fdebc-a23d-499f-b51a-ecd9dbea37c6

Device Description

To be used in nitrous-oxide-oxygen sedation systems. The Vacuum Control Block is a safety feature and is used to monitor and precisely adjust the vacuum/suction levels.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	868.2340	1

GMDN Terms

Code	Name	Definition	Implantable	Status
37705	Ventilator breathing circuit, reusable	An assembly of devices designed to conduct air or oxygen (O2) enriched gases and additional gases [e.g., nitrous oxide (N2O), halogenated gases] from a ventilator, or other air-delivery therapeutic device such as a mechanical insufflator/exsufflator, to a patient. It includes breathing tubes, a Y-piece connector, and provides connections for devices that humidify, deliver medication, and monitor gas concentration or pressure within the breathing circuit. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260635790684	GS1