Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)
Spirometry Tube, Disposable, 6M/20FT
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (4), 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 |
Record
| Listed by | GE Healthcare Finland OY, Finland |
|---|---|
| FDA product code | NHQ |
| Device type | Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Record published | 2016-08-15 |
| Record revised | 2025-04-29 (version 11) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 66 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 90 % RH; Handling environment humidity 10 to 98 % RH |
| Packaging | Bag of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Spirometry Tube, disposable, 6m/20ft | In distribution | |
| E-sCAiOVX-00 | In distribution | |
| E-sCOV-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ISA™ AX+ | Masimo Corporation | 2 |
| NomoLine ISA™ AX+ | Masimo Corporation | 1 |
| UltraviewSL | Spacelabs Healthcare (Washington), Inc | 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.