3ML Steri-Neb Saline - 0.9% W/V Sodium Chloride Inhalation Solution Usp
510(k) K980829
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK980829 | Date2 Jun 1998 | 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- Withdrawn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, 23 Sep 2026
The 3Ml Steri-Neb Saline is a 0.9% w/v sodium chloride inhalation solution. It is used for inhalation purposes. The device is a type of inhalation solution, with a concentration of 0.9% w/v sodium chloride.
The device is supplied in a 3ml format and is sterile. It is a single-use device. The device has been cleared with a Traditional 510K clearance. The device is available in the US, with the manufacturer being Steripak, Ltd.
Other devices from Steripak, Ltd.
Questions
AI-generated answers, 23 Sep 2026
What is the Steri-Neb Saline used for?
The Steri-Neb Saline is used for inhalation purposes, providing a 0.9% w/v sodium chloride solution.
Is the Steri-Neb Saline sterile?
Yes, the Steri-Neb Saline is supplied in a sterile format, ensuring a single-use device with minimal risk of contamination.
What is the concentration of sodium chloride in the Steri-Neb Saline?
The Steri-Neb Saline has a concentration of 0.9% w/v sodium chloride, making it suitable for inhalation purposes.
Is the Steri-Neb Saline a single-use device?
Yes, the Steri-Neb Saline is designed as a single-use device, reducing the risk of contamination and ensuring patient safety.