WoodyKnows
6 catalogue numbers from SD2, listed by M&M Pure AIR Systems LLC, United States, under Nasal Spray, Ent Delivery. 23 manufacturers in China are registered for this product code.
23manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (12), Zhejiang (4), Jiangsu (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Firstar Healthcare Company Limited (Guangzhou) | Guangzhou | Guangdong | Contract manufacturer | 57 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Hynaut Health Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 68 |
| Ningbo Tianbo First AID Product Co., Ltd. | Ningbo | Zhejiang | Repacker / relabeller | 66 |
| Dongguan City Ruimi Gift Products Co Ltd | Dongguan | Guangdong | Repacker / relabeller | 62 |
| Ningbo Just Soon Industrial Limited | Ningbo | Zhejiang | Repacker / relabeller | 36 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
| Shenzhen Homed Medical Device Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 13 |
| Shenzhen Linglu Hongtu Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Guangdong Titan Smart Electrical Appliance Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 10 |
Showing 12 of 23. All 23 manufacturers in China registered for Nasal Spray, Ent Delivery
Record
| Listed by | M&M Pure AIR Systems LLC, United States |
|---|---|
| FDA product code | KCO |
| Device type | Nasal Spray, Ent Delivery |
| Device class | Class 1 |
| Regulation | 21 CFR 874.5220 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-05-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2026-05-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD2 | Withdrawn | |
| SD1 | Withdrawn | |
| UB3 | Withdrawn | |
| UB1 | Withdrawn | |
| SD3 | Withdrawn | |
| UB2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nasal PCA | GO Medical Industries PTY. Ltd. | 5 |
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 2 |
| Naväge Baby | Rhinosystems, Inc. | 2 |
| Inbrija® | Merz Pharmaceuticals, LLC | 1 |
| Eau de Quinton Daily Nasal Hygiene 100 ml | Laboratoires Quinton International SL | 1 |
| Eau de Quinton Action Plus Nasal Hygiene 100 ml | Laboratoires Quinton International SL | 1 |
| Eau de Quinton Pediatric Nasal Hygiene 100 ml | Laboratoires Quinton International SL | 1 |
| Sinucleanse Nasal DRY Salt Inhaler | Ascent Consumer Products, Inc. | 1 |
| Mentholatum(R) VaporDuo(TM) | Mentholatum Company, THE | 1 |
| Sinucleanse Bronchial DRY Salt Inhaler | Ascent Consumer Products, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.