A1000 Single Use Syringe Kit
A1000 Single Use Syringe Kit, p/n 801060-003 Kit Contents: 100mL contrast reservoir and tubing with contrast spike and clamp.
15manufacturers in China registered for this device type
2catalogue numbers in this listing
12510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Guangdong (7), Jiangsu (3), Shandong (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Jiangxi Baoeran Biomedical Science & Technology Co., Ltd. | Fuzhou | Jiangxi | Contract manufacturer | 1 |
| Suzhou Meccan Import and Export Corp. | Suzhou | Jiangsu | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Shandong INT Medical Instruments Co., Ltd. | Rizhao | Shandong | Manufacturer | 4 |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 4 |
| Shenzhen Antmed Co., Ltd. | Dongguan | Guangdong | Manufacturer | 4 |
Showing 12 of 15. All 15 manufacturers in China registered for Injector And Syringe, Angiographic
Record
| Listed by | Acist Medical Systems, Inc., United States |
|---|---|
| FDA product code | DXT |
| Device type | Injector And Syringe, Angiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2019-10-09 |
| Record revised | 2025-12-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, shelf box of 10 |
| Distribution end date | 2021-03-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 016606 | Withdrawn | |
| 016606 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sinton Medical Products | Shenzhen Boon Medical Supply Co., Ltd. | 199 |
| DeRoyal | Deroyal Industries, Inc. | 138 |
| Antmed | Shenzhen Antmed Co., Ltd. | 91 |
| Medline Industries, Inc. | Medline Industries, Inc. | 59 |
| LF | Liebel-Flarsheim Company LLC | 58 |
| Namic | Medline Industries, Inc. | 50 |
| Merit Medical® | Merit Medical Systems, Inc. | 46 |
| Medical Imaging Solutions International | Shenzhen Boon Medical Supply Co., Ltd. | 43 |
| LF | Shenzhen Boon Medical Supply Co., Ltd. | 38 |
| Namic | Navilyst Medical, Inc. | 38 |
| Coeur | Coeur, Inc. | 38 |
| Medical Imaging Solutions Intl. | Medical Imaging Solutions, Inc. | 37 |
Showing 12 of 168. All products under Injector And Syringe, Angiographic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252653 | 2026-05-13 |
| K252638 | 2026-05-13 |
| K203004 | 2020-12-17 |
| K191060 | 2019-07-18 |
| K171646 | 2018-02-16 |
| K052744 | 2005-12-16 |
| K040298 | 2004-03-15 |
| K020892 | 2003-01-27 |
| K010390 | 2001-03-09 |
| K991103 | 2000-05-31 |
| K000013 | 2000-03-28 |
| K993774 | 1999-12-07 |
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2015-12-21 | Class II | Nonconforming Material/Component | Reports related to ingress of air into the manifold. | 48,614 cartons or 486,140 units | 2016-07-22 |
| 2013-03-15 | Class II | Nonconforming Material/Component | ACIST Medical Systems is issuing a voluntary recall notice for three specific lots of BT2000 Automated Manifold Kits. For these specific lots, ACIST has received field reports related to ingress of air into the manifold body. This has been | 6640 units | 2013-08-07 |
| 2009-05-11 | Not classified | Nonconforming Material/Component | ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsa | 62, 280 (57,110 US, 5130 Canada, 40 Hong Kong) | 2012-02-04 |
| 2008-11-10 | Not classified | Software design | Multiple Injections may result. It has been determined that when using the ACIST CVi Angiographic Injection system to synchronize with the Toshiba Infinix -i cardiovascular x-ray system there is an injection scenario that may result in mul | 18 cables | 2011-05-07 |
| 2008-06-06 | Not classified | Package design/selection | Some of the sterile package seals of AT P54 AngioTouch Kit were breached. Breached package seals could compromise product sterility, which could potentially lead to patient infection. | 11,750 (USA), 22,230 (OUS) | 2011-01-25 |
| 2007-10-03 | Not classified | Process design | Syringe Fracture: the syringe may be fractured, causing contrast to be sprayed from syringe fracture. | 177,050 Kits | 2008-10-06 |
| 2004-05-19 | Not classified | Other | Some of the sterile product packages were inadequately sealed prior to sterilization and as a result the package contents may not be sterile. | 3590 kits | 2005-11-03 |
| 2003-10-02 | Not classified | Other | Some of the automated manifold’s 2.5 inch high-pressure lines for radiopaque contrast media, used in angiographic procedures, have separated where they are bonded to the manifold body of the device allowing contrast media to leak. | 7120 kits | 2005-11-23 |
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.