Negavent Plus Pegaso Cough, Model DA-3 Plus
by Dima Italia Srl EUDAMED510(k)
Active
510(k) K072292
Overview
The Negavent Plus Pegaso Cough, Model DA-3 Plus, is a non-invasive, microprocessor-controlled device classified as a Positive Pressure Breathing, Intermittent system. It is designed to simulate a cough by delivering controlled cycles of positive and negative airway pressure to assist in clearing bronchopulmonary secretions in patients with impaired cough function.
This device is intended for use in clinical settings, such as anesthesia or respiratory care, and is supplied as a reusable medical device. It operates using a brushless blower to generate the required pressure cycles and has received FDA 510(k) clearance under the Traditional pathway. The device adheres to the Medical Device Directive (MDD) and is categorized under Class II in the regulatory framework.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK072292 | Date7 Jan 2008 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NHJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5905
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dima Italia Srl
Questions
What clinical scenarios is the Negavent Plus Pegaso Cough, Model DA-3 Plus, primarily intended to assist with?
The Negavent Plus Pegaso Cough, Model DA-3 Plus, is designed to simulate a cough by delivering controlled cycles of positive and negative airway pressure. It is specifically intended for patients with impaired cough function, helping to clear bronchopulmonary secretions in clinical settings such as anesthesia or respiratory care.
Is the Negavent Plus Pegaso Cough reusable or single-use, and how is it powered?
The Negavent Plus Pegaso Cough is supplied as a reusable medical device. It operates using a built-in brushless blower to generate the required pressure cycles for simulating a cough, eliminating the need for external power sources.
What regulatory pathways has the Negavent Plus Pegaso Cough, Model DA-3 Plus, followed, and what classification does it hold?
The device has received FDA 510(k) clearance under the Traditional pathway and adheres to the Medical Device Directive (MDD). It is classified as a Class II medical device in the regulatory framework, indicating a moderate risk level that requires specific controls.
Are there multiple models or sizes available for the Negavent Plus Pegaso Cough, and how would I identify them?
The provided data lists multiple registration numbers (e.g., 3011120183, 3042507287) associated with the Negavent Plus Pegaso Cough, which may correspond to different models or configurations. These identifiers are used in regulatory filings, but the core device described is the Model DA-3 Plus. For precise sizing or model variations, refer to the manufacturer’s documentation or contact Dima Italia Srl.
How should the Negavent Plus Pegaso Cough be stored, and are there any special handling requirements?
Since the device is reusable, it should be stored in a clean, dry environment following manufacturer guidelines to maintain functionality and hygiene. The data does not specify storage conditions, but standard practices for reusable medical devices—such as avoiding moisture, extreme temperatures, and contamination—should be followed. Always consult the manufacturer’s instructions for detailed storage protocols.