Pts Collect™ Capillary Tubes
The tubes are a combination of a short glass capillary pipette that is physically combined with a plastic pipette that is capable of dispensing a given volume of blood from the capillary…
The tubes are a combination of a short glass capillary pipette that is physically combined with a plastic pipette that is capable of dispensing a given volume of blood from the capillary tube to a test strip. The glass capillary draws blood from a finger stick site using capillary force. Two small vents in the plastic bulb allow for capillary action. After drawing up of the blood into the glass tube, the two small vents in the plastic tube are then covered with two fingers and the bulb is squeezed to dispense the blood. The PTS Collect capillary tubes are single-use, disposable devices.
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 | Polymer Technology Systems, United States |
|---|---|
| FDA product code | GIO |
| Device type | Tube, Collection, Capillary Blood |
| Device class | Class 1 |
| Regulation | 21 CFR 864.6150 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-18 |
| Record revised | 2023-04-26 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-04-24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 2865 | 25 | In distribution | |
| 2874 | 25 | In distribution | |
| 2866 | 16 | In distribution | |
| 2863 | 25 | In distribution | |
| 2864 | 25 | Withdrawn | |
| 2134 | 25 | Withdrawn |
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 |
| Microsafe® | Safe-Tec Clinical Products, Inc. | 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 |
| 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
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.