Prime Alert
Catalogue number PA001, listed by Life Technologies Corporation, United States, under System, Measurement, Blood-Pressure, Non-Invasive. 98 manufacturers in China are registered for this product code.
98manufacturers in China registered for this device type
1catalogue number
55510(k) clearances naming this product code
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 | Life Technologies Corporation, United States |
|---|---|
| FDA product code | DXN |
| Device type | System, Measurement, Blood-Pressure, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1130 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-02-27 |
| Record revised | 2023-08-14 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | serial number |
| Storage | Storage environment temperature -25 to 70 °C; Handling environment temperature 5 to 40 °C; Handling environment atmospheric pressure 700 to 1060 KiloPascal |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA001 | In distribution |
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 |
|---|---|
| K211127 | 2021-09-08 |
| K200521 | 2020-06-12 |
| K190507 | 2019-09-16 |
| K190133 | 2019-06-13 |
| K190134 | 2019-05-20 |
| K180240 | 2018-10-17 |
| K162338 | 2016-09-21 |
| K160557 | 2016-07-06 |
| K161156 | 2016-06-14 |
| K160336 | 2016-03-29 |
| K160145 | 2016-03-13 |
| K153214 | 2016-01-07 |
| K150311 | 2015-08-18 |
| K142968 | 2014-12-19 |
| K130564 | 2013-06-19 |
| K130563 | 2013-06-18 |
| K131121 | 2013-05-29 |
| K113239 | 2012-03-16 |
| K113238 | 2012-03-01 |
| K112320 | 2011-09-30 |
| K093831 | 2010-03-25 |
| K093824 | 2010-02-16 |
| K093823 | 2010-01-22 |
| K092163 | 2009-11-16 |
| K092161 | 2009-09-30 |
| K060835 | 2006-04-21 |
| K060729 | 2006-04-12 |
| K050714 | 2005-04-07 |
| K050711 | 2005-04-07 |
| K050587 | 2005-04-05 |
| K050491 | 2005-03-31 |
| K050249 | 2005-03-30 |
| K043437 | 2005-01-12 |
| K043186 | 2004-12-06 |
| K042853 | 2004-11-10 |
| K042802 | 2004-10-26 |
| K042265 | 2004-08-31 |
| K032839 | 2003-10-10 |
| K033043 | 2003-10-10 |
| K032837 | 2003-10-10 |
| K032913 | 2003-10-02 |
| K032695 | 2003-10-02 |
| K031695 | 2003-07-01 |
| K031835 | 2003-07-01 |
| K030541 | 2003-04-24 |
| K030499 | 2003-04-17 |
| K030498 | 2003-04-11 |
| K023834 | 2003-01-14 |
| K020766 | 2002-04-05 |
| K014122 | 2002-01-16 |
| K013033 | 2001-10-23 |
| K012310 | 2001-08-22 |
| K002882 | 2000-10-13 |
| K002750 | 2000-09-18 |
| K990807 | 1999-12-03 |
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.