QMT Nimbus Antimicrobial Barrier Gauze Dressing
by Quick-Med Technologies, Inc.
De Novo DEN070002
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA De NovoDENG | NumberDEN070002 | Date25 Feb 2009 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA De Novo Active
Specification
- De Novo Number
- FDA Product Code
- NYS
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4015
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- DENG De Novo granted
Overview
AI-generated summary, 1 Oct 2026
The QMT Nimbus Antimicrobial Barrier Gauze Dressing is a wound dressing infused with poly(diallyl dimethyl ammonium chloride) (PDADMAC), designed to provide a sustained antimicrobial barrier. It falls under the category of wound dressings with antimicrobial properties, specifically targeting microbial contamination in wound care. The dressing is formulated to prevent microbial growth while maintaining wound integrity without leaching antimicrobial agents.
This dressing is supplied as a single-use, sterile product intended for use in general and plastic surgery settings. It is classified as a Class II medical device under FDA regulations (21 CFR 878.4015) and holds a 510(k) clearance (DEN070002). The dressing is packaged to ensure sterility and should be stored according to manufacturer guidelines to maintain its antimicrobial efficacy. No MRI safety information is specified, and its reusable or non-reusable status is not indicated in the data.
Other devices from Quick-Med Technologies, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the QMT Nimbus Antimicrobial Barrier Gauze Dressing used for?
This dressing is designed to create a sustained antimicrobial barrier over wounds, specifically to prevent microbial contamination while maintaining wound integrity. The antimicrobial agent, poly(diallyl dimethyl ammonium chloride) (PDADMAC), is infused into the gauze to inhibit microbial growth without leaching, making it ideal for surgical settings where infection control is critical.
Is the QMT Nimbus Antimicrobial Barrier Gauze Dressing sterile and single-use?
Yes, the dressing is supplied as a sterile, single-use product. Sterility is maintained during packaging to ensure safety for one-time clinical application, and it is not intended for reuse.
How should the QMT Nimbus Antimicrobial Barrier Gauze Dressing be stored?
The dressing must be stored according to the manufacturer’s guidelines to preserve its antimicrobial efficacy and sterility. Proper storage conditions typically include protection from moisture, extreme temperatures, and direct light, as outlined in the packaging instructions.
Can this dressing be used in MRI environments?
The provided data does not specify MRI safety information for the QMT Nimbus Antimicrobial Barrier Gauze Dressing. Clinicians should verify compatibility with their MRI equipment and protocols before use.
What regulatory clearance does the QMT Nimbus Antimicrobial Barrier Gauze Dressing hold?
The dressing holds FDA 510(k) clearance under the designation DEN070002, classified as a Class II medical device under 21 CFR 878.4015. This clearance confirms it meets regulatory standards for antimicrobial wound dressings in general and plastic surgery applications.