Irma Airway Adapter
IRMA Airway Adapter Infant
6manufacturers in China registered for this device type
2catalogue 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 | Masimo Corporation, United States |
|---|---|
| FDA product code | CBS |
| Device type | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1620 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-08-11 |
| Record revised | 2024-09-16 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 106260 | 10 | In distribution | |
| 106220 | 25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | Philips Medizin Systeme Böblingen GmbH | 3 |
| Irma™ AX+ | Masimo Corporation | 3 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Healthcare Finland OY | 2 |
| Waveline Pro+ | Avante | 2 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 1 |
| Carescape Canvas D19 | GE Healthcare Finland OY | 1 |
| IntelliVue G7m Gas Analyzer Module | Philips Medizin Systeme Böblingen GmbH | 1 |
| Waveline Touch+ | Avante | 1 |
| Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | GE Medical Systems Information Technologies, Inc. | 1 |
| Waveline EZ-MAX | Avante | 1 |
| Carescape RAD | GE Healthcare Finland OY | 1 |
| Water Trap | Philips Medizin Systeme Böblingen GmbH | 1 |
Showing 12 of 13. All products under Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
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.