ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG

Basic Information

• Brand Name: ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG
• Primary DI: 07898671250496
• Version / Model: 1709953
• Catalog Number: 1709953
• Company Name: MAGNAMED TECNOLOGIA MEDICA SA
• Labeler DUNS: 944224603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-05-29
• Public Version: 1
• Public Version Date: 2025-06-06
• Public Version Status: New
• Public Device Record Key: e6bf8b52-3799-4f71-b986-ce90af799934

Device Description

KIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, AND DIAPHRAGM FOR USE WITH OXYMAG, SINGLE-USE

Device Characteristics

• Single Use: Yes
• 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
BYX	Tubing, Pressure And Accessories	Anesthesiology	868.5860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46824	Mechanical expiratory valve, single-use	A non-sterile mechanical device intended to be used in a respiratory or anaesthesia breathing circuit or system to maintain a degree of positive pressure in a patient's airway at the end of expiration. Typically constructed of plastic/metal it has a valve that is actuated by a spring to provide expiratory airway resistance, and an adjustable knob (usually not graduated) that is typically set between 0 and 20 cmH20 pressure, but may be fully closed when controlled/assisted ventilation is applied. It is normally used with anaesthesia breathing systems, pulmonary resuscitators, or ventilators and is commonly known as a pop-off valve, relief valve, or spill valve. This is a single-use device.	No	Active
61692	Breathing circuit gas-flow sensor, single-use	A sterile device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07898671250496	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]