Salter Labs Nebulizer Exhalation Aerosol Filter
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by Salter Labs
Identity
- Trade Name
- Filter EUDAMEDN/A FDA UDI
- Generic Name
- Oxygen administration tubing FDA UDI
- Device Name
- Filter FDA UDI
- Model / Reference
- 1001-0-25 EUDAMEDFDA UDISalter Sleep Diagnostic Cannulas EUDAMED
- Description
- Filter FDA UDI
Identifiers
- Catalog Number
- 1001-0-25 FDA UDI
- Primary DI / UDI-DI
- 00607411000980 EUDAMEDFDA UDI
- Basic UDI-DI
- 0607411TF20010_SleepDx9V EUDAMED
- 510(k) Number
- K983403 FDA 510(k)
- FDA Product Code
- CAF FDA 510(k)BYX FDA UDI
- EMDN Code
- Z12100585 POLYSOMNOGRAPHY INSTRUMENTS - CONSUMABLES EUDAMED
- GMDN Term
- Oxygen administration tubing FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDIClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 868.5630 FDA 510(k)
- Regulation Number
- 868.5630 FDA 510(k)868.5860 FDA UDI
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
The Salter Labs Nebulizer Exhalation Aerosol Filter is a filter device designed to capture exhaled air and prevent contamination of inhaled medication in nebulizer systems. It functions as a one-way valve, allowing only inspired aerosol to pass while blocking exhaled breath, thereby improving medication delivery efficiency and reducing cross-contamination. This accessory is specifically intended for use with nebulizer compressors to enhance therapeutic aerosol therapy.
This filter is supplied as a standalone accessory for integration with compatible nebulizer systems, such as the Salter Labs Aire Elite series. It is intended for single-use applications to maintain sterility and hygiene, though compatibility with reusable nebulizer setups may vary based on manufacturer guidelines. The device adheres to FDA 510(k) clearance under the Anesthesiology advisory committee (K983403) and MDR compliance, ensuring regulatory alignment for medical use. Storage should follow manufacturer instructions to preserve functionality, and proper disposal after single-use is recommended.
Frequently asked questions
What is the primary purpose of the Salter Labs Nebulizer Exhalation Aerosol Filter in a nebulizer system?
The filter is designed to capture exhaled air and prevent it from contaminating inhaled medication within nebulizer systems. By acting as a one-way valve, it allows only inspired aerosol to pass through while blocking exhaled breath, which improves the efficiency of medication delivery and minimizes cross-contamination risks during therapy.
Is the Salter Labs Nebulizer Exhalation Aerosol Filter intended for single-use or reusable applications?
The filter is explicitly intended for single-use applications to ensure sterility and hygiene. While it may technically fit into some reusable nebulizer setups, compatibility depends on the specific manufacturer’s guidelines for those systems. Single-use is recommended to maintain optimal performance and prevent contamination.
Which nebulizer systems is this filter designed to work with, and how is it supplied?
The filter is supplied as a standalone accessory and is specifically intended for integration with compatible nebulizer systems, such as the Salter Labs *Aire Elite series*. It is not a standalone nebulizer but rather an add-on component to enhance aerosol therapy efficiency when used with approved nebulizer compressors.
How should the filter be stored, and what are the disposal recommendations after use?
Storage instructions should follow the manufacturer’s guidelines to preserve the filter’s functionality. Since it is intended for single-use, proper disposal after use is recommended to avoid contamination and ensure hygiene. Always adhere to local medical waste disposal protocols.
What regulatory pathways does the Salter Labs Nebulizer Exhalation Aerosol Filter follow, and how does this affect its use?
The filter holds FDA 510(k) clearance under the Anesthesiology advisory committee (K983403) and complies with MDR (Medical Device Regulation) standards. This clearance indicates it has been deemed *substantially equivalent* to a predicate device, ensuring it meets regulatory requirements for safe and effective use in medical settings as described in its intended purpose.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Nebulizer Accessories - justNebulizers.com Tagged "Salter Labs" - Just ..., Air Filters for Salter Labs Aire Elite Nebulizer 850112- Pack/2, Manufacturer Tagged "Salter Labs" - Just Nebulizers, Salter Labs Aire Elite & Plus Compressor Replacement Parts, Filter, Bag ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K983403 | Class II | Active |
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Manufacturer
- Manufacturer
- Salter Labs
Sources (3)
- FDA 510(k) K983403 24 fields · synced Sep 20, 2026
- FDA UDI 825b8482-babc-45a4-8dfe-c4059ed613dc 36 fields · synced May 30, 2026
- EUDAMED b9ffe713-17c1-46f4-b917-9be2a430700d 61 fields · synced Jul 19, 2026