Waveline EZ-MAX
Catalogue number 60145T10CO2ES, listed by Avante, under Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.). 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
1catalogue number
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 | Avante |
|---|---|
| FDA product code | CBS |
| Device type | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.1620 |
| 510(k) | K131971 |
| Record published | 2016-09-23 |
| Record revised | 2021-11-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60145T10CO2ES | 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 |
| Irma Airway Adapter | Masimo Corporation | 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 |
| 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.)
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Edan Diagnostics, Inc. | 510(k) number | 2025-10-24 | Class II | Device Design | As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device. | 14550 | |
| Edan Diagnostics, Inc. | 510(k) number | 2016-06-23 | Class II | Nonconforming Material/Component | Incorrect CO2 readings with some patient monitors. | 521 | 2016-11-16 |
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.