WhisperPak, Face Mask, Case 10
WhisperPak, Face Mask, Case 10: 1 catalogue number listed by Respironics Novametrix, LLC, United States, under Attachment, Breathing, Positive End Expiratory Pressure. 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 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 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Shenzhen Wellcore Well Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Respironics Novametrix, LLC, United States |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2017-09-01 |
| Record revised | 2021-06-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Multipack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-MAX | Pulmodyne Inc. | 136 |
| 02-MAX | Pulmodyne Inc. | 83 |
| 02-RESQ | Pulmodyne Inc. | 43 |
| Flow-Safe II Disposable CPAP System | Mercury Medical Enterprises, LLC | 36 |
| Curaplex® | Bound Tree Medical, LLC | 31 |
| AincA | Anesthesia Associates, Inc. | 30 |
| Flow-Safe Disposable CPAP System | Mercury Medical Enterprises, LLC | 29 |
| Attachment, Breathing, Positive End Expiratory Pressure | Galemed Corp. | 25 |
| Shiley | Covidien LP | 21 |
| Infant Resuscitation Kit. T-Piece Circuit | Flexicare Medical Ltd. | 20 |
| AirLife | Carefusion | 17 |
| O2-RESQ | Pulmodyne Inc. | 17 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
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.