DEVICE: ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG (07898671250496)
Device Identifier (DI) Information
ADUL/PED SINGLE USE ACCESSORY KIT FOR OXYMAG
1709953
In Commercial Distribution
1709953
MAGNAMED TECNOLOGIA MEDICA SA
1709953
In Commercial Distribution
1709953
MAGNAMED TECNOLOGIA MEDICA SA
KIT WITH UNIVERSAL FLOW SENSOR, FLOW SENSOR LINE, EXHALATION VALVE, AND DIAPHRAGM FOR USE WITH OXYMAG, SINGLE-USE
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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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.
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Active | false |
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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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BYX | Tubing, Pressure And Accessories |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
e6bf8b52-3799-4f71-b986-ce90af799934
June 06, 2025
1
May 29, 2025
June 06, 2025
1
May 29, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1 (954) 658-2689
contact@magnamedusa.com
contact@magnamedusa.com