EnsoETM
The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral…
The EnsoETM is a thermal regulating device, intended to connect to a Cincinnati Sub-Zero Norm-O-Temp Hyperthermia System to raise or maintain a patient’s temperature, allow enteral administration of fluid, and provide gastric decompression and suctioning. The EnsoETM is packaged with a universal bite block, an ENFit transition adaptor, and lubrication jelly.
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 | Advanced Cooling Therapy, LLC, United States |
|---|---|
| FDA product code | PIO |
| Device type | Enteral Specific Transition Connectors |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2018-09-08 |
| Record revised | 2025-07-08 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Shipping box, shelf box of 4 |
| Distribution end date | 2022-10-04 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ECD05-A | Withdrawn |
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 |
| 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 |
| 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
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.