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INTERTECH/INSPIRON (R) Medication Nebulizer Kit

【Unique Mask Design】The mask features a special design with a non-curved nose section, ensuring comfort during use. Crafted from soft materials and equipped with a flexible rope, the mask adjusts to fit a wide range of face sizes comfortably.

【Premium Quality Materials】Made with PVC and applicable polymer materials, providing durability and compactness.

【For Compatible Nebulizer Systems】The air tubes, masks, mouthpieces, and medicine canisters are designed for use with compatible nebulizer systems.

【Reusable and Cleanable】This accessory kit is reusable by a single patient. To maintain hygiene and ensure optimal performance, please clean the kit after each use.

【Lightweight and Portable】Lightweight and easy to carry for home or travel use.

Product Description

The INTERTECH/INSPIRON (R) Medication Nebulizer Kit is intended for over-the-counter use with compatible nebulizer systems. The kit provides replacement patient interface and delivery components, including masks, medicine canisters, mouthpieces, and air tubes, to provide a delivery pathway through a mask or mouthpiece according to the product labeling.

FDA Establishment Registration & Device Listing

Proprietary Name:Medication Nebulizer; Portex Small Volume Medication Nebulizer; Portex Small Volume Medication Nebulizer Kit

Classification Name:NEBULIZER (DIRECT PATIENT INTERFACE)

Product Code:CAF

Device Class:2

Regulation Number:868.5630

Medical Specialty:Anesthesiology

Registered Establishment Name:ICU Medical Healthcare Manufacturing S.A. de C.V.

Registered Establishment Number:9617604

Premarket Submission Number:K896923

Owner/Operator:ICU Medical, Inc.

Owner/Operator Number:8020727
Establishment Operations:Manufacturer

Registration Number: 9617604
FEI Number*: 3002558692

Owner/Operator Number:8020727