QualityREG

Basic Information

• Brand Name: QualityREG
• Primary DI: 04251411706029
• Version / Model: DM-AD-CO2-NIST-DIN-K
• Catalog Number: DM-AD-CO2-NIST-DIN-K
• Company Name: DEHAS Medical Systems GmbH
• Labeler DUNS: 343728657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-24
• Public Version: 1
• Public Version Date: 2024-08-01
• Public Version Status: New
• Public Device Record Key: b42278f3-1482-433f-908f-61b01705f5e0

Device Description

Quick plug adapter NIST / DIN with safety Chain, adapter NIST / coupling with chain and ring.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAN	Regulator, Pressure, Gas Cylinder	Anesthesiology	868.2700	1
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
43438	Non-fixed medical gas cylinder regulator	A reduction valve designed to be attached through a gastight connector (e.g., a pin-index or bull-nosed screw thread connection) to the valve stem of a medical gas (e.g., carbon dioxide, oxygen, nitrous oxide, gas mixture) cylinder to reduce high, variable gas pressure to a lower, constant working pressure (excludes procedure-dedicated valves). It can be a single or a dual stage regulator, usually of a piston or diaphragm design. It will have a safety relief valve to avoid excessive pressure due to increased ambient temperatures, and it may have associated devices (e.g., a manometer, flowmeter) to display the available gas reserve of a gas cylinder, the working pressure and/or the flow rate.	No	Active
66374	Carbon dioxide low pressure hose	A length of reinforced colour-coded flexible tubing produced according to ISO5359 and intended to conduct compressed carbon dioxide (CO2) from a CO2 terminal unit or CO2 cylinder to a medical device that functions with CO2 (e.g., ventilator, insufflation system). The gas pressure in the tubing will be low, a "working pressure" (e.g., 3 - 5 bar), having been reduced by a regulator from a high pressure. The tubing is reinforced with, e.g., woven polyester or cotton, and intended for use within a static clinical environment (e.g., intensive care). It is available in various lengths, including standard coil lengths. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04251411706029	GS1