Hudson RCI
Circuit, NEO, Dual HTD, Dual Limb,column
1manufacturer
12catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Avita (Wujiang) Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 15 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | OGG |
| Device type | Humidifier Nebulizer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Premarket notification | Exempt |
| Record published | 2025-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Keep dry. Keep away from sunlight. |
| Packaging | Case of 20, case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HUD88015KIT | In distribution | |
| HUD78018KIT | In distribution | |
| HUD88017KIT | In distribution | |
| HUD87098KITF | In distribution | |
| HUD88014KIT | In distribution | |
| HUD87035KIT | In distribution | |
| HUD88037KIT | In distribution | |
| HUD88034KIT | In distribution | |
| HUD87098KIT | In distribution | |
| HUD88013KIT | In distribution | |
| HUD78001KIT | In distribution | |
| HUD88009KIT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 156 |
| AirLife | Carefusion | 10 |
| AirLife™ | Airlife, Inc. | 9 |
| Yirdoc | Qingdao Future Medical Technology Co., Ltd. | 4 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2 |
| Composite Respiratory Kit | Westmed, Inc. | 1 |
| Seattle PAP plus | Drägerwerk AG & Co. KGaA | 1 |
| Curaplex | Bound Tree Medical, LLC | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-07-13 | Class II | Under Investigation by firm | Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. D | 271406 units |
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.