Microsafe®
8 catalogue numbers from 1040-50, listed by Safe-Tec Clinical Products, Inc., United States, under Tube, Collection, Capillary Blood. 16 manufacturers in China are registered for this product code.
16manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (4), Shandong (4), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Infitek Co., Ltd. | Shanghai | Shanghai | Manufacturer | 49 |
| Diatrust Medical Co., Ltd. | Nanjing | Jiangsu | Manufacturer | 48 |
| Labpeak Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Scitek Global Co., Ltd. | Jinan | Shandong | Manufacturer | 43 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Weihai Kangzhou Biotechnology Engineering Co., Ltd. | Weihai | Shandong | Manufacturer | 24 |
| Xiamen Zhiyuan Medical Technology Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 22 |
| Zhejiang Saining Biotechnology Co., Ltd. | Taizhou | Zhejiang | Manufacturer | 12 |
| Medico Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
Showing 12 of 16. All 16 manufacturers in China registered for Tube, Collection, Capillary Blood
Record
| Listed by | Safe-Tec Clinical Products, Inc., United States |
|---|---|
| FDA product code | GIO |
| Device type | Tube, Collection, Capillary Blood |
| Device class | Class 1 |
| Regulation | 21 CFR 864.6150 |
| Premarket notification | Exempt |
| Record published | 2021-01-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1040-50 | 50 | In distribution | |
| 1015-50 | 50 | In distribution | |
| 1015-10 | 10 | In distribution | |
| 1020-50 | 50 | In distribution | |
| 1030-50 | 50 | In distribution | |
| 1050-50 | 50 | In distribution | |
| 1010S-50 | 50 | In distribution | |
| 1075-50 | 50 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Globe Scientific | Globe Scientific, LLC | 25 |
| Microsafe | Drummond Scientific Co. | 24 |
| LT Tube for PRP | Zhuhai Longtime Biological Technology Co., Ltd. | 13 |
| LT Kit for PRP | Zhuhai Longtime Biological Technology Co., Ltd. | 12 |
| Baixin | Anhui Kangda Medical Products Co., Ltd. | 10 |
| QBC Diagnostics | Drucker Diagnostics, LLC | 8 |
| MultiCap pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb | Siemens Healthcare Diagnostics Inc | 7 |
| Safe-T-Fill® | Ram Scientific | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 6 |
| pts collect™ Capillary Tubes | Polymer Technology Systems | 6 |
| MultiCap-S pH/ Blood Gas/Na+/K+/Ca++/Cl-/Glu/Lac/tHb | Siemens Healthcare Diagnostics Inc | 6 |
| Marketlab Inc | Marketlab Incorporated | 4 |
Showing 12 of 120. All products under Tube, Collection, Capillary Blood
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K884623 | 1988-12-01 |
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.