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The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) - systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2),…
The V20, V20a, AVSM3 SNF are intended to be used to monitor noninvasive blood pressure(NIBP) – systolic, diastolic and mean arterial pressures, functional arterial oxygen saturation(SpO2), pulse rate (PR) and temperature (TEMP) in all areas of a hospital and hospital-type facilities. Monitor users should be skilled at the level of a technician, doctor, nurse or medical specialist. The V20 and V20a are for adult, pediatric and neonatal patients and the AVSM3 SNF is for adult patients only. Also, the V20 is only suitable for single measurement but V20a and AVSM3 SNF are suitable for single as well as continuous measurement.
Who Else Makes It
Concentrated in Guangdong (67), Jiangsu (11), Zhejiang (6). 17 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 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Honsun (Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 9 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Guangzhou Daxin Health Technology (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 7 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Dongguan Polygreen Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 4 |
| Shenzhen Brav Electronic Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 3 |
Showing 12 of 98. All 98 manufacturers in China registered for System, Measurement, Blood-Pressure, Non-Invasive
Record
| Listed by | Mediana Co., Ltd., South Korea |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K170497 |
| Record published | 2018-01-23 |
| Record revised | 2021-11-10 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2018-01-25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AVM-1 | In distribution | |
| AVSM3 | In distribution | |
| AVM-1 | In distribution | |
| AVSM3 | In distribution | |
| AVSM3 | In distribution | |
| AVSM2 | In distribution | |
| AVSM2 | In distribution | |
| AVSM2 | Withdrawn | |
| AVSM2 | Withdrawn | |
| AVSM2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Baum | W.A. Baum Co., Inc. | 116 |
| Alphamed | Shenzhen Urion Technology Co., Ltd. | 68 |
| Electronic Blood Pressure Monitor | Shenzhen Pango Electronic Co., Ltd. | 59 |
| Arm Type Automatic Blood Pressure Monitor | Shenzhen Jiacom Technology Co., Ltd. | 58 |
| A&D Medical | A&D Company, Ltd. | 56 |
| Diagnostix™ | American Diagnostic Corp. | 54 |
| Lutech | Lutech Industries | 51 |
| Veridian | Veridian Healthcare | 50 |
| Hopkins Medical Products® | Hopkins Uniform Company | 49 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 49 |
| Merit Medical® | Argon Critical Care Systems Singapore PTE. Ltd. | 48 |
| SunTech | Suntech Medical, Inc. | 46 |
Showing 12 of 1,292. All products under System, Measurement, Blood-Pressure, Non-Invasive
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200434 | 2020-10-09 |
| K170497 | 2017-12-15 |
| K152659 | 2016-08-25 |
| K051375 | 2005-07-28 |
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 |
|---|---|---|---|---|---|---|---|
| Mediana Co., Ltd. | 510(k) number | 2021-05-17 | Class II | Nonconforming Material/Component | In some cases the equipment fails to power up and/or key or button unresponsive or not working. | 618 | 2022-11-04 |
| Mediana Co., Ltd. | 510(k) number | 2020-05-15 | Class II | Process change control | Failures were found in the temperature measurement function while in the predict mode. | 180 devices | 2022-09-16 |
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.