ENFit Transition Adapter
Male ENFit-to-Stepped Male (Christmas Tree) Adapter (Pouched), MDR
4manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
1recall
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 | Applied Medical Technology, Inc., United States |
|---|---|
| FDA product code | PIO |
| Device type | Enteral Specific Transition Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K150034 |
| Record published | 2025-05-28 |
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 |
| Packaging | Box (trn204) of 10, box (trn201) of 10, box (trn202) of 10, box (trn203) of 10, box (trn101) of 10, box (trn102) of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETRN204 | In distribution | |
| ETRN201 | In distribution | |
| ETRN202 | In distribution | |
| ETRN203 | In distribution | |
| ETRN101 | In distribution | |
| ETRN102 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| AMT Enfit® Transition Adapter | Applied Medical Technology, Inc. | 6 |
| Enteral distal end ENFit Transition Connector | Cedic SRL | 4 |
| Medline | Medline Industries, Inc. | 2 |
| 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 |
|---|---|
| K150034 | 2015-06-09 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|---|---|
| Applied Medical Technology, Inc. | 510(k) number | 2020-11-10 | Class III | Labeling Change Control | The products subject to this recall may contain obvious, incorrect pouch labels while the outer box has the correct label. | 2021-09-03 |
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.