NM3 Monitor, Spanish
Catalogue number 7900, listed by Respironics Novametrix, LLC, United States, under Spirometer, Monitoring (W/Wo Alarm). 5 manufacturers in China are registered for this product code.
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 | Respironics Novametrix, LLC, 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, Manufacturer |
| Record published | 2016-09-22 |
| Record revised | 2021-06-24 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -30 to 60 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7900 | 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 |
| Respiratory Mechanics Combined Flow/CO2 Sensor → Pediatric | Draeger Medical Systems, Inc. | 1 |
| NM3 Monitor, Dutch | Respironics Novametrix, LLC | 1 |
| NM3, English, Demo Unit | Respironics Novametrix, LLC | 1 |
Showing 12 of 20. All products under Spirometer, Monitoring (W/Wo Alarm)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103578 | 2011-06-02 |
| K092217 | 2009-08-21 |
| K091459 | 2009-07-28 |
| K080652 | 2008-06-20 |
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 |
|---|---|---|---|---|---|
| 2011-07-29 | Not classified | Manufacturing material removal | Pressure lines maybe occluded and display incorrect tidal volumes. | 41 units | 2012-05-23 |
| 2011-07-29 | Not classified | Manufacturing material removal | Pressure lines maybe occluded and display incorrect tidal volumes. | 254 units | 2012-05-23 |
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.