ECG Printer Paper, 100MM
100MM ECG Paper ECG, UDI
9manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Physio-Control, Inc., United States |
|---|---|
| FDA product code | DSF |
| Device type | Recorder, Paper Chart |
| Device class | Class 1 |
| Regulation | 21 CFR 870.2810 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Pack of 2, case of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 11240 | 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 |
| ECG Recording Paper | Diagramma AG | 16 |
| 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 |
Showing 12 of 851. All products under Recorder, Paper Chart
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K881346 | 1988-06-09 |
| K880554 | 1988-05-06 |
| K760676 | 1976-10-13 |
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.