SteriPath Gen2, Luer
The Steripath Gen2 Luer blood collection system obtains blood samples for in vitro diagnostic testing. It diverts and retains the initial portion of a draw before collecting a subsequent…
The Steripath Gen2 Luer blood collection system obtains blood samples for in vitro diagnostic testing. It diverts and retains the initial portion of a draw before collecting a subsequent sample, helping reduce blood-culture contamination when contaminants are present in that initial portion.
The first blood enters a diversion reservoir. Once diversion is complete, subsequent blood travels through a second pathway into a culture bottle or a syringe used to inoculate culture bottles. The 2700-EN configuration includes a Luer extension inlet and a transfer adapter outlet.
Listed Item
Steripath Blood Collection System, Sterile Pack, Luer, Wide Neck TA
After Collection
Following removal of the initial specimen diversion device, compatible system components may be used for infusion under their instructions. Infusion through venipuncture needles 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 | 2024-04-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| 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 |
| Packaging | Sales pack of 10, transport pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2700-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.