Tamper Evident Cap for Use With ENFit Syringes
The Tamper Evident Cap for ENFit Syringes closes an enteral syringe to help prevent loss of fluid and contamination of its contents before use. Its design also provides visible evidence…
The Tamper Evident Cap for ENFit Syringes closes an enteral syringe to help prevent loss of fluid and contamination of its contents before use. Its design also provides visible evidence that the closure may have been accessed. The listed purple configuration is supplied non-sterile.
The assembly contains an acrylic syringe tip cap with a male ENFit connector, surrounded by a restrictive polystyrene sleeve and bottom cover. The sleeve covers the locking cap and must be removed to access it. A damaged or missing sleeve indicates possible tampering.
Listed Item
Tamper Evident Cap for use with ENFit Syringes, Purple. Non-sterile. Bag of 100. Package of 1000. Provides positive closure and tamper evidence.
Compatibility and Use
The cap is intended for enteral syringes with ENFit connectors. It is a single-use disposable accessory. Its closure and tamper-evidence functions act on the syringe contents until the syringe is ready for use.
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang | Anhui | Contract manufacturer | 9 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
| Shantou Wealy Medical Instrument Co., Ltd. | Shantou | Guangdong | Contract manufacturer | 10 |
| Jiangsu Kangbao Medical Equipment Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Micsafe Medical Technology Co., Ltd. | Yancheng | Jiangsu | Manufacturer | 9 |
Showing 12 of 13. All 13 manufacturers in China registered for Enteral Syringes With Enteral Specific Connectors
Record
| Listed by | Tech Industries. Inc., United States |
|---|---|
| FDA product code | PNR |
| Device type | Enteral Syringes With Enteral Specific Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K170672 |
| Record published | 2018-01-29 |
| Record revised | 2026-01-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Box of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 57-220 R | 100 | In distribution | |
| 57-220 | 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enteral | Gbuk Group Limited | 51 |
| Enteral Syringes With Enteral Specific Connectors | Ningbo Tianyi Medical Appliance Co., Ltd. | 48 |
| Kbmed | KB Medical (Group) Inc. | 31 |
| ENFit Syringe | Avanos Medical, Inc. | 30 |
| Health Care Logistics, Inc® | Health Care Logistics, Inc. | 24 |
| Ameritus ENFit | Kentec Medical, LLC | 22 |
| NeoConnect Pharmacy Syringe | Neomed Co., Ltd. | 21 |
| Monoject | Cardinal Health 200, LLC | 19 |
| NeoConnect Oral / Enteral Syringe | Neomed Co., Ltd. | 16 |
| Medline | Medline Industries, Inc. | 16 |
| Monoject | Cardinal Health | 14 |
| micsafe | Jiangsu Micsafe Medical Tehcnology Co., Ltd. | 13 |
Showing 12 of 70. All products under Enteral Syringes With Enteral Specific Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K170672 | 2017-10-06 |
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.