SteriPath Gen2, 21g
SteriPath Gen2 is a blood collection system that diverts and isolates the first 1.5 to 2 mL of a blood draw before collecting the test sample. This separates the initial portion, which may…
SteriPath Gen2 is a blood collection system that diverts and isolates the first 1.5 to 2 mL of a blood draw before collecting the test sample. This separates the initial portion, which may contain contaminants, from blood subsequently collected for diagnostic testing.
The 2700-21-EN configuration combines an initial specimen diversion device, a 21 gauge blood collection set and a transfer adapter. After diversion, blood follows a second pathway for collection into a culture bottle.
Listed Item
Steripath Blood Collection System, Sterile Pack, 21G, Wide Neck TA
Supply and Subsequent Use
The system is supplied sterile for single use. After the diversion device is disconnected, eligible components may be used for infusion according to their instructions. Infusion through the butterfly needle is limited to less than two hours.
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 | Magnolia Medical Technologies, Inc., United States |
|---|---|
| FDA product code | JKA |
| Device type | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1675 |
| Establishment | Manufacturer |
| 510(k) | K192247 |
| Record published | 2020-11-06 |
| Record revised | 2022-01-06 (version 4) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Sales pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2700-21-EN | In distribution |
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 |
| Safe-T-Fill® | Ram Scientific | 23 |
| 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 |
Showing 12 of 303. All products under Tubes, Vials, Systems, Serum Separators, Blood Collection
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251812 | 2025-09-25 |
| K222299 | 2022-11-30 |
| K192247 | 2020-02-28 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Magnolia Medical Technologies, Inc. | 510(k) number | 2021-11-02 | Class II | Process control | Due to an uptick of complaints associated with premature needle retraction of blood collection system. | 137,200 devices | 2023-05-08 |
| Magnolia Medical Technologies, Inc. | 510(k) number | 2021-08-02 | Class II | Labeling Change Control | Product was shipped with the incorrect Transfer Adapter Instructions For Use (IFU). | 9,400 units | 2023-02-22 |
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.