Safe-T-Fill®
SAFE-T-FILL Plastic Blood Gas Capillary Tubes, 230 µL; Prepared with Balanced Heparin
16manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Ram Scientific, 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 | 2022-10-01 |
| Record revised | 2025-12-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry. Keep away from sunlight. |
| Packaging | Package of 4 |
| Sizes | Total volume 115 to 230 Microliter |
| Distribution end date | 2025-05-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 06 0007 | Total Volume 150 Microliter | 250 | Withdrawn |
| 06 0187 | Total Volume 230 Microliter | 250 | Withdrawn |
| 06 0005 | Total Volume 115 Microliter | 250 | Withdrawn |
| 06 0185 | Total Volume 115 Microliter | 250 | Withdrawn |
| 06 0186 | Total Volume 150 Microliter | 250 | Withdrawn |
| 06 0199 | Total Volume 150 Microliter | 250 | Withdrawn |
| 06 0009 | Total Volume 230 Microliter | 250 | 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 |
| 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
Recalls Naming This Product
7 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 397000 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 352750 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 77500 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 1000 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 947100 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 160250 |
| ASP Global, LLC | UDI-DI | 2025-09-26 | Class II | Process change control | Due to products manufactured under an inadequate quality system to include unvalidated manufacturing processes. | 121750 |
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.