NUP · Cream, Nasal, Topical, Mechanical Allergen Particle Barrier
General Hospital · 21 CFR 880.5045 · Class 2
Overview
| Product Code | NUP |
|---|---|
| Device Name | Cream, Nasal, Topical, Mechanical Allergen Particle Barrier |
| Regulation | 21 CFR 880.5045 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
Identification
A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K213114 | BentrioTM Allergy Blocker | Altamira Therapeutics, Inc. | Jun 24, 2022 | SESE |
| K201734 | AllerBlock Junior | Nasaleze International, Ltd. | Mar 26, 2021 | SESE |
| K170848 | Alzair Allergy Blocker | Nasaleze International, Ltd. | Jun 14, 2017 | SESE |
| K134003 | RHINIX NASAL FILTER | Rhinix Aps | Sep 4, 2014 | SESE |
| K132520 | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | Dec 31, 2013 | SESE |
| K120894 | HAYMAX | Haymax Limited | May 17, 2012 | SESE |
| K053625 | NASALGUARD | Trutek Corp | Feb 22, 2006 | SESE |
| K042610 | DR. THEISS ALERGOL POLLEN BLOCKER CREAM | Dr. Theiss Naturwaren GmbH | May 16, 2005 | SESE |
Top Applicants
- Nasaleze International, Ltd. — 2 clearances
- Altamira Therapeutics, Inc. — 1 clearance
- Dr. Theiss Naturwaren GmbH — 1 clearance
- Haymax Limited — 1 clearance
- Hi-Tech Pharmacal, Inc. — 1 clearance
