Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
D-Lite++ Patient Spirometry SET, 3M/10FT, 1 PCS
6manufacturers in China registered for this device type
4catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| 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 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | CBR |
| Device type | Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1700 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K211171 |
| Record published | 2016-06-16 |
| Record revised | 2025-04-29 (version 9) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 98 % RH; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment temperature -20 to 60 °C; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 66 to 106 KiloPascal |
| Packaging | Box of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pedi-lite sensor, reusable, Pediatric | In distribution | |
| E-sCAiOV-00 | In distribution | |
| E-sCAiOVE-00 | In distribution | |
| D-LITE PATIENT SPIROMETRY SET 2104297-002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 3 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| 19″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 22″display(adapter/2.3M | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 1 |
| AG Module(O2/package/accessory) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| 19″display(adapter/10M/VP1) | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
| Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Spacelabs | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape B850 | GE Healthcare Finland OY | 1 |
| SMR integrated mount accessory Kit | Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | 1 |
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.