Respiratory Mechanics Combined Flow/CO2 Sensor – Pediatric
Catalogue number 5957142, listed by Draeger Medical Systems, Inc., United States, under Spirometer, Monitoring (W/Wo Alarm). 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (3), Jiangsu (1), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Draeger Medical Systems, Inc., United States |
|---|---|
| FDA product code | BZK |
| Device type | Spirometer, Monitoring (W/Wo Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1850 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2015-11-02 |
| Record revised | 2024-08-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5957142 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 18 |
| KoKo | KoKo PFT Ltd. | 3 |
| Spirometer, Monitoring (W/Wo Alarm) | GE Healthcare Finland OY | 3 |
| nSpire Health | Nspire Health, Inc. | 3 |
| NM3 Monitor, Portuguese | Respironics Novametrix, LLC | 1 |
| NM3 Monitor, English, Refurbished | Respironics Novametrix, LLC | 1 |
| Respiratory Mechanics Combined Flow/CO2 Sensor → Adult/pediatric | Draeger Medical Systems, Inc. | 1 |
| NM3 Monitor, French | Respironics Novametrix, LLC | 1 |
| NM3 Monitor, German | Respironics Novametrix, LLC | 1 |
| NM3 Monitor, Dutch | Respironics Novametrix, LLC | 1 |
| NM3, English, Demo Unit | Respironics Novametrix, LLC | 1 |
| CapMedic® | Cognita Labs LLC | 1 |
Showing 12 of 20. All products under Spirometer, Monitoring (W/Wo Alarm)
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.