[Production License Number] Sujiang Medical Device Production License No. 20240191
[Product Registration Certificate Number] Su Medical Device Registration No. 20252081994
[Product Technical Requirements Number] Su Medical Device Registration No. 20252081994
[Product Name] Single-use Oxygen Nebulizer [Model Specifications]: Mask Type, Mouthpiece Type
【Structural Composition】 Single-use oxygen nebulizers are classified into two types based on their shape: mask-type and mouthpiece-type. The mask-type consists of a mask, a securing strap, a nebulization chamber, and an oxygen delivery tube; the mouthpiece-type consists of a nebulization chamber, a mouthpiece, a mask (optional), a securing strap (optional), and an oxygen delivery tube. The masks are available in four sizes: extra-large, large, medium, and small; the nebulization chambers are available in two configurations: side-connection and vertical-connection. This product is supplied in a sterile condition, sterilized with ethylene oxide, and is for single use only.
【Product Performance】
1. Maximum atomization rate: ≥0.1 mL/min
2. Residual drug volume: ≤0.5 mL
3. Mass Median Diameter (MMD) of the mist droplets: 5 μm ± 1 μm; the proportion of droplets with a diameter less than 5 μm is <40%.
Test method: laser diffraction.
Test solution: 0.9% normal saline
Test conditions: ambient temperature of 20°C and relative humidity of 53%, with a test distance of 10 cm from the mist outlet.
【Scope of Application】
It is used to nebulize liquid medications, which are then inhaled by the patient to achieve the intended therapeutic effect.
【Contraindications】
Do not use if you are allergic to PP or PVC materials. Please confirm that you have no relevant history of allergy before use.
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Single-use oxygen nebulizer
Single-use oxygen nebulizer
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