Spirometer, Monitoring (W/Wo Alarm)
Pedi-Lite+ Spirometry KIT 3M/10FT, M1032634
5manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | GE Healthcare Finland OY, Finland |
|---|---|
| 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, Manufacturer |
| 510(k) | K052582 |
| Record published | 2016-08-12 |
| Record revised | 2025-04-29 (version 10) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment atmospheric pressure 66 to 106 KiloPascal; Handling environment humidity 10 to 98 % RH; Handling environment temperature 10 to 40 °C; Storage environment temperature -25 to 60 °C |
| Packaging | Box of 10, box of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Mini D-fend Water Trap, 8002174 | In distribution | |
| Pedi-Lite Spirometry Kit 3m, M1032634 | In distribution | |
| E-sCO-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AincA® | Anesthesia Associates, Inc. | 18 |
| KoKo | KoKo PFT Ltd. | 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 |
| 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.