Safe-T-Fill®
SAFE-T-FILL® Micro Capillary Blood Collection, 200 µL; Prepared with Clot Activator and Serum Separator Gel; Amber Microtube, Red
23manufacturers in China registered for this device type
23catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (6), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 21 |
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Weihai Jierui Medical Products Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Tianjin Hanaco Medical Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Medicines & Health Products I/ E Co., Ltd. | Hangzhou | Zhejiang | Exporter | 41 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| Zhejiang Kindly Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Jiangsu Rongye Technology Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 16 |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 11 |
| Shanghai Mekon Medical Devices Co., Ltd. | Shanghai | Shanghai | Exporter | 11 |
Showing 12 of 23. All 23 manufacturers in China registered for Tubes, Vials, Systems, Serum Separators, Blood Collection
Record
| Listed by | Ram Scientific, United States |
|---|---|
| FDA product code | JKA |
| Device type | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Record published | 2016-09-15 |
| Record revised | 2025-12-23 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep Dry.; Special storage condition: Keep away from sunlight. |
| Packaging | Case of 10, carton of 80, carton of 60, carton of 100, case of 20, carton of 160 |
| Sizes | Total volume 125 to 300 Microliter; total volume 1 ml |
| Distribution end date | 2025-05-16 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 07 6014 | Total Volume 150 Microliter | Withdrawn | |
| 07 7340 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 6013 | Total Volume 125 Microliter | 50 | Withdrawn |
| 07 7250 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7151 | Total Volume 300 Microliter | 50 | Withdrawn |
| 07 7120 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7421 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7121 | Total Volume 300 Microliter | 50 | Withdrawn |
| 07 8021 | Total Volume 1 ml | 50 | Withdrawn |
| 07 7220 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7150 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 6011 | Total Volume 125 Microliter | 50 | Withdrawn |
| 07 8052 | Total Volume 1 ml | 50 | Withdrawn |
| 07 7251 | Total Volume 300 Microliter | 50 | Withdrawn |
| 07 7450 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 6101 | Total Volume 125 Microliter | 50 | Withdrawn |
| 07 7056 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7455 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7221 | Total Volume 300 Microliter | 50 | Withdrawn |
| 07 7053 | Total Volume 300 Microliter | 50 | Withdrawn |
| 07 7052 | Total Volume 150 Microliter | 50 | Withdrawn |
| 07 7058 | Total Volume 200 Microliter | 50 | Withdrawn |
| 07 7051 | Total Volume 200 Microliter | 50 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 182 |
| S-Monovette® | Sarstedt Aktiengesellschaft & Co.KG | 108 |
| Vacuette | Greiner BIO-ONE Gmbh | 106 |
| Jelco | ICU Medical, Inc | 35 |
| Kbmed | KB Medical (Group) Inc. | 33 |
| Marketlab Inc | Marketlab Incorporated | 30 |
| Maveric Medical | Maveric Medical LLC | 27 |
| Improvacuter® Gel & Clot Activator Tube | Guangzhou Improve Medical Instruments Co., Ltd. | 21 |
| Medline | Medline Industries, Inc. | 20 |
| Kurin Blood Culture Collection Set | Kurin, Inc. | 20 |
| Reli | Myco Medical Supplies, Inc. | 18 |
| icu medical | Jiangsu Caina Medical Co., Ltd. | 18 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K983517 | 1998-11-12 |
| K981973 | 1998-09-03 |
Recalls Naming This Product
11 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. | 78000 |
| 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. | 50050 |
| 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. | 64850 |
| 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. | 27950 |
| 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. | 6600 |
| 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. | 49000 |
| 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. | 9150 |
| 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. | 103200 |
| 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. | 6050 |
| 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. | 2100 |
| 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. | 1500 |
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.