Neb-U-Mask System, Models 1895, 1896
510(k) K080230
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK080230 | Date9 Jun 2008 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CAF
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5630
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Neb-U-Mask System, Models 1895 and 1896, is a jet nebulizer assembly designed for the concurrent delivery of aerosolized medications with high-concentration oxygen or heliox. It combines a non-rebreathing mask with a valved wye adaptor, an MDI port, a 750 mL reservoir bag, and a small-volume nebulizer. This configuration ensures efficient aerosol generation and inhalation therapy, particularly for patients requiring both medication and respiratory support. The device is classified under the anesthesiology advisory committee category and is intended for use in clinical settings where precise aerosol delivery is critical.
The system is supplied as a reusable kit, including all components necessary for immediate use. It is not sterile and must be cleaned and disinfected between patients per manufacturer guidelines. The device is MRI-unsafe due to its metallic components and should not be used in magnetic resonance imaging environments. Models 1895 and 1896 are authorized under FDA 510(k) clearance (K080230) and are intended for use in adult respiratory therapy. Proper storage requires a clean, dry environment to maintain functionality and hygiene.
Other devices from Teleflex Medical, LLC
Questions
AI-generated answers, 1 Oct 2026
What is the Neb-U-Mask System (Models 1895, 1896) used for?
The Neb-U-Mask System combines a non-rebreathing mask, valved wye adaptor, MDI port, reservoir bag, and small-volume nebulizer to deliver aerosolized medications alongside high-concentration oxygen or heliox. This design ensures efficient aerosol generation and inhalation therapy, particularly for patients needing concurrent respiratory support and medication delivery in clinical settings.
Is the Neb-U-Mask System reusable or single-use?
The Neb-U-Mask System is supplied as a reusable kit, including all necessary components for immediate use. However, it is not sterile and must be thoroughly cleaned and disinfected between patient use to maintain hygiene and functionality, following manufacturer guidelines.
Can the Neb-U-Mask System be used in an MRI environment?
No, the Neb-U-Mask System contains metallic components that make it MRI-unsafe. It should never be used in magnetic resonance imaging environments due to potential interference or safety risks.
What storage conditions are required for the Neb-U-Mask System?
The device should be stored in a clean, dry environment to preserve functionality and hygiene. Proper storage conditions help prevent contamination and ensure the components remain operational for repeated use.
Are Models 1895 and 1896 intended for pediatric or adult use?
The Neb-U-Mask System (Models 1895 and 1896) is specifically authorized for use in adult respiratory therapy. While the design supports precise aerosol delivery, its intended application is for adult patients in clinical settings.