Waveline Touch+
Catalogue number 60145T, listed by Avante, under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm). 9 manufacturers in China are registered for this product code.
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (1), Hebei (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| 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 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
Record
| Listed by | Avante |
|---|---|
| FDA product code | DRT |
| Device type | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2300 |
| 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 |
|---|---|---|
| 60145T | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Model 7600 | IVY Biomedical Systems, Inc. | 82 |
| Model 7800 | IVY Biomedical Systems, Inc. | 66 |
| ECG | Zoll Medical Corporation | 30 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden America, Inc. | 18 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | Nihon Kohden Corp. | 12 |
| Model 7600EP | IVY Biomedical Systems, Inc. | 11 |
| Propaq M | Zoll Medical Corporation | 11 |
| Model 7700 | IVY Biomedical Systems, Inc. | 11 |
| CTM-300 | IVY Biomedical Systems, Inc. | 6 |
| Cable | Zoll Medical Corporation | 5 |
| Upmm | IVY Biomedical Systems, Inc. | 4 |
| ViSi | Sotera Wireless | 4 |
Showing 12 of 43. All products under Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
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.