Medline
Enfit SET Transition Connector, Medline
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Kangjin Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 13 |
| Aena Medical (Jiangsu) Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 4 |
| Hangzhou Best Valley Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Exporter | 20 |
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | PIO |
| Device type | Enteral Specific Transition Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Record published | 2020-12-17 |
| Record revised | 2026-03-26 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from freezing. Avoid excessive heat. |
| Packaging | Case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENFIT1000TC | In distribution | |
| ENFIT1010GC | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMT Enfit® Transition Adapter | Applied Medical Technology, Inc. | 6 |
| ENFit Transition Adapter | Applied Medical Technology, Inc. | 6 |
| Enteral distal end ENFit Transition Connector | Cedic SRL | 4 |
| Enteral ENFit Transition Connector with cap for medication port | Cedic SRL | 2 |
| Enteral Funnel ENFit Transition Connector with cap | Cedic SRL | 2 |
| ENConnect ENFit to Oral/Luer syringe adapter | Cedic SRL | 1 |
| Enteral Distal End ENFit Transition Connector with cap | Cedic SRL | 1 |
| ENConnect ENFit Funnel Adapter | Cedic SRL | 1 |
| EnsoETM | Advanced Cooling Therapy, LLC | 1 |
| Kangaroo | Cardinal Health 200, LLC | 1 |
| ENConnect Male Distal End Stepped Adapter | Cedic SRL | 1 |
| ENFit to Reverse Luer Transition Connector | Cedic SRL | 1 |
Showing 12 of 16. All products under Enteral Specific Transition Connectors
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K151628 | 2015-07-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2026-02-13 | Class II | Process change control | Connectors were not manufactured to required dimensional specifications and may not form a proper seal with ENFit-style devices, which could lead to leakage. Leakage may result in delayed care and fluid loss. Additional consequences may als | 651,789 |
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.