Remstar Passover Humidifier
Catalogue number REMstar Passover Humidifier, listed by Respironics Inc., United States, under Humidifier, Respiratory Gas, (Direct Patient Interface). 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (2), Fujian (1). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Shenzhen MED-Link Electronics Tech Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 18 |
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Betacera Inc. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Ninghai Guangjie Electronic Commerce Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 3 |
| Vincent Medical(Dongguan)Technology Company Limited | Dongguan | Guangdong | Contract manufacturer | 2 |
Record
| Listed by | Respironics Inc., United States |
|---|---|
| FDA product code | BTT |
| Device type | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5450 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K945782 |
| Record published | 2018-06-26 |
| Record revised | 2022-10-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Storage environment temperature -20 to 60 °C; Handling environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F |
| Distribution end date | 2022-10-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| REMstar Passover Humidifier | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hudson RCI | Teleflex Medical LLC | 160 |
| Fisher & Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 151 |
| Vapotherm | Vapotherm Inc. | 134 |
| Humidifier, Respiratory Gas, (Direct Patient Interface) | Salter Labs | 96 |
| Hudson RCI | Medline Industries, Inc. | 41 |
| AirLife™ | Airlife, Inc. | 27 |
| Fisher and Paykel Healthcare | Fisher & Paykel Healthcare, Ltd. | 20 |
| F&P Optiflow Junior 2 | Fisher & Paykel Healthcare, Ltd. | 17 |
| MR850 | Fisher & Paykel Healthcare, Ltd. | 13 |
| AirLife | Carefusion | 13 |
| softFlow | TNI Medical AG | 11 |
| F&P Optiflow+ | Fisher & Paykel Healthcare, Ltd. | 7 |
Showing 12 of 138. All products under Humidifier, Respiratory Gas, (Direct Patient Interface)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K030090 | 2003-01-24 |
| K012633 | 2002-02-28 |
| K964653 | 1997-02-14 |
| K945782 | 1996-03-01 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2006-10-25 | Not classified | Other | AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device | 235 units | 2009-12-15 |
| 2006-10-25 | Not classified | Other | AC inlet connector failure that can result in thermal damage to the humidifier enclosure and/or ignition of materials external to the device | 172,000 units | 2009-12-15 |
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.