ECG Recording Paper
Cardiovit AT-2, CS-200, AT-2plus, AT-170, AT-180
9manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (2). 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 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| 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 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Xiamen MK Health Care Product Co., Ltd. | Xiamen | Fujian | Manufacturer | 7 |
| Tianjin Grand Paper Industry Co., Ltd. | Tianjin | Tianjin | Manufacturer | 2 |
Record
| Listed by | Diagramma AG, Switzerland |
|---|---|
| FDA product code | DSF |
| Device type | Recorder, Paper Chart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.2810 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-01-17 |
| Record revised | 2023-10-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment humidity up to 65 % RH; Storage environment temperature up to 30 °C |
| Packaging | Pack of 10, pack of 25, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2.157052 | In distribution | |
| 2.157056 | In distribution | |
| 2.157047 | In distribution | |
| 2.157054 | In distribution | |
| 2.157049 | In distribution | |
| 2.157058 | In distribution | |
| 2.157059 | In distribution | |
| 2.157039 | In distribution | |
| 04121 | In distribution | |
| 2.157046 | In distribution | |
| 2.157040 | In distribution | |
| 2.157050 | In distribution | |
| 2.157051 | In distribution | |
| 2.157057 | In distribution | |
| 2.157053 | In distribution | |
| 2.157055 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vermed | Graphic Controls Acquisition Corporation | 153 |
| Cardinal Health | Cardinal Health 200, LLC | 91 |
| Kendall | Cardinal Health | 54 |
| Henry Schein | Henry Schein, Inc. | 31 |
| non branded | Cardinal Health | 28 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 16 |
| MediChoice | Owens & Minor Distribution, Inc. | 15 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 13 |
| GE Healthcare | Graphic Controls Acquisition Corporation | 12 |
| Paper | Philips Medical Systems Hsg | 12 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Vital Signs™ | AirLife Finland Oy | 5 |
Showing 12 of 851. All products under Recorder, Paper Chart
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.