ISA™ AX+
2 catalogue numbers from AX+ LEMO, listed by Masimo Corporation, United States, under Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration). 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue 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 | Masimo Corporation, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-11 |
| Record revised | 2024-09-16 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AX+ LEMO | In distribution | |
| AX+ | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) | GE Healthcare Finland OY | 3 |
| 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.