Tamper Evident Cap
RECORD OBSOLETE: 57-301 RECLASSIFIED AS PACKAGE CONFIG OF 57-25 CE "Sterile Blue Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and…
RECORD OBSOLETE: 57-301 RECLASSIFIED AS PACKAGE CONFIG OF 57-25 CE “Sterile Blue Tamper Evident Luer Lock Caps for IV Syringes, in bulk transfer tray. Provides evidence of access and maintains sterility. Packaged using double sterile barrier system: 10 caps per tray (with tyvek lid), 10 trays per Tyvek pouch, and 7 pouches per shipping box for a total of 700 caps per box.”
Who Else Makes It
Concentrated in Jiangsu (16), Zhejiang (15), Shanghai (11). 12 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| BQ Plus Medical Co., Ltd. | Songjiang | Shanghai | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Zhejiang Runqiang Medical Instruments Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 9 |
| Wuxi Yushou Medical Appliances Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 8 |
| Pine Moon Electronics Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Zhejiang INI Medical Devices Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 4 |
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| Hantech (Ningbo) Medical Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 3 |
Showing 12 of 60. All 60 manufacturers in China registered for Syringe, Piston
Record
| Listed by | Tech Industries. Inc., United States |
|---|---|
| FDA product code | FMF |
| Device type | Syringe, Piston |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5860 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K231095 |
| Record published | 2020-03-05 |
| Record revised | 2026-01-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 100, box of 10, tyvek pouch of 21, box of 7, box of 70, pack of 10 |
| Distribution end date | 2026-01-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 57-26-100 | 10 | In distribution | |
| 17360WC | 10 | In distribution | |
| 5780W | In distribution | ||
| 57-26 FSS | 10 | In distribution | |
| 57-80 | In distribution | ||
| 57-50 W | 10 | In distribution | |
| 17360RC | 10 | In distribution | |
| 17360K | 10 | In distribution | |
| 57-30 | 10 | In distribution | |
| 57-300 W | 100 | In distribution | |
| 5780K | In distribution | ||
| 57-50 R | 10 | In distribution | |
| 57-350 R | 100 | In distribution | |
| 5780B | In distribution | ||
| 17360BC | 10 | In distribution | |
| 17360B | 10 | In distribution | |
| 57-25 CE | 10 | In distribution | |
| 57-26 STAQ | 10 | In distribution | |
| 17361R | In distribution | ||
| 57-350 W | 100 | In distribution | |
| 57-300 B | 100 | In distribution | |
| 57-25-100 | 10 | In distribution | |
| 57-24 CE | 10 | In distribution | |
| 57-300 R | 100 | In distribution | |
| 57-24-100 | 10 | In distribution | |
| 57-26 CE | 10 | In distribution | |
| 57-24 STAQ | 10 | In distribution | |
| 57-350 B | 100 | In distribution | |
| 57-50 B | 10 | In distribution | |
| 17360R | 10 | In distribution | |
| 57-25 QUVA | 10 | In distribution | |
| 17360W | 10 | In distribution | |
| ISOTEC-B | 10 | Withdrawn | |
| 57-301 B | 10 | Withdrawn | |
| 57-64 | 10 | Withdrawn | |
| 57-302W STAQ | 100 | Withdrawn | |
| 57-302 FSS | 1,000 | Withdrawn | |
| ISOTEC-W | 10 | Withdrawn | |
| 57-302 FSS | 100 | Withdrawn | |
| TEC10 | 10 | Withdrawn | |
| 57-351 R | 10 | Withdrawn | |
| 17360KC | 10 | Withdrawn | |
| 57-302W STAQ | 1,000 | Withdrawn | |
| ISOTEC-R | 10 | Withdrawn | |
| TEC10-B | 10 | Withdrawn | |
| 57-301 W | 10 | Withdrawn | |
| 57-301 R | 10 | Withdrawn | |
| TEC10-W | 10 | Withdrawn | |
| 57-302R STAQ | 1,000 | Withdrawn | |
| 57-351 W | 10 | Withdrawn | |
| 57-50 K | 10 | Withdrawn | |
| 57302R STAQ | 10 | Withdrawn | |
| 57-351 B | 10 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Yeso med | Wuxi Yushou Medical Appliances Co., Ltd. | 228 |
| Medallion® | Merit Medical Systems, Inc. | 223 |
| Merit Medical® | Merit Medical Systems, Inc. | 192 |
| Monoject | Cardinal Health | 188 |
| Medline | Medline Industries, Inc. | 127 |
| EasyTouch | MHC Medical Products | 122 |
| Medline Industries, Inc. | Medline Industries, Inc. | 99 |
| Arrow | Teleflex Medical LLC | 94 |
| Ceros | Rhino Medical Supply Inc | 92 |
| Enteral Feeding | Medela LLC | 87 |
| Monoject | Cardinal Health 200, LLC | 83 |
| HSW Soft-Ject® | Henke-Sass Wolf, Gmbh. | 80 |
Showing 12 of 913. All products under Syringe, Piston
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K231095 | 2024-09-04 |
| K193192 | 2020-01-31 |
| K861276 | 1986-05-05 |
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.