CareSens N POP
CareSens N POP measures glucose in capillary whole blood for people with diabetes who test themselves at home. It works with CareSens N Single test strips to support monitoring of a…
CareSens N POP measures glucose in capillary whole blood for people with diabetes who test themselves at home. It works with CareSens N Single test strips to support monitoring of a diabetes control program. The system is intended for one person and must not be shared.
Glucose reacts with the strip reagent to produce a small electrical current. The meter converts that current into a glucose concentration. A lancing device and lancets obtain the blood sample, while separate control solutions check that the meter and strips work together properly.
Listed Item
CareSens N POP Blood Glucose Monitoring System
Sampling Limits
Fingertip and specified alternative sites can be used, but alternative site testing is limited to steady blood glucose conditions. The system is not intended for newborns or for diagnosing or screening for diabetes.
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | I-Sens, Inc., South Korea |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K120351 |
| Record published | 2020-11-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Storage | Storage environment temperature 32 to 122 °F |
| Packaging | Master case carton of 70 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 164422 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K230625 | 2023-08-10 |
| K201394 | 2021-10-05 |
| K192859 | 2020-01-24 |
| K193590 | 2020-01-17 |
| K192220 | 2019-12-13 |
| K181273 | 2018-11-01 |
| K180866 | 2018-08-31 |
| K171480 | 2017-12-13 |
| K170614 | 2017-10-19 |
| K160742 | 2016-12-16 |
| K151164 | 2015-08-07 |
| K133346 | 2013-12-19 |
| K132288 | 2013-11-22 |
| K130696 | 2013-08-21 |
| K131419 | 2013-08-09 |
| K121133 | 2012-07-10 |
| K120351 | 2012-05-03 |
| K103396 | 2011-09-27 |
| K100937 | 2010-12-21 |
| K083468 | 2009-02-10 |
| K080923 | 2008-10-17 |
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.