Ameritus ENFit
10fr 110cm single port feeding tube with ENFit connector
3manufacturers in China registered for this device type
38catalogue numbers in this listing
1510(k) clearance
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Kentec Medical, LLC, United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K100526 |
| Record published | 2016-08-12 |
| Record revised | 2019-07-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 200, box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ENF-Y80P-80 | In distribution | |
| ENF-80P-50 | In distribution | |
| ENF-Y50P-40 | In distribution | |
| ENF-Y80P-90 | In distribution | |
| ENF-Y80P-40 | In distribution | |
| ENF-40P-40 | In distribution | |
| ENF-Y60P-80 | In distribution | |
| ENF-80P-90 | In distribution | |
| ENF-40P-80 | In distribution | |
| ENF-50P-40 | In distribution | |
| ENF-Y60P-90 | In distribution | |
| ENF-Y60P-50 | In distribution | |
| ENF-Y80P-50 | In distribution | |
| ENF-60P-80 | In distribution | |
| ENF-50P-110 | In distribution | |
| ENF-50P-50 | In distribution | |
| ENF-Y50P-90 | In distribution | |
| ENF-60P-110 | In distribution | |
| ENF-60P-40 | In distribution | |
| ENF-80P-50U | In distribution | |
| ENF-50P-90 | In distribution | |
| ENF-50P-50U | In distribution | |
| ENF-80P-80 | In distribution | |
| ENF-60P-90 | In distribution | |
| ENF-40P-50 | In distribution | |
| ENF-80P-110 | In distribution | |
| ENF-100P-110 | In distribution | |
| ENF-80P-40 | In distribution | |
| ENF-Y60P-90U | In distribution | |
| ENF-Y50P-50 | In distribution | |
| ENF-60P-50 | In distribution | |
| ENF-Y60P-40 | In distribution | |
| ENF-Y80P-90U | In distribution | |
| ENF-50P-80 | In distribution | |
| ENF-Y100P-90 | In distribution | |
| ENF-Y50P-80 | In distribution | |
| ENF-60P-50U | In distribution | |
| ENF-40P-90 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 236 |
| Ameritus | Kentec Medical, LLC | 83 |
| Avanos | Avanos Medical, Inc. | 51 |
| Halyard | Avanos Medical, Inc. | 50 |
| MED-RX | Canadian Hospital Specialties Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 20 |
| ENFit SIL Feeding Tube | Avanos Medical, Inc. | 18 |
| NeoConnect Enteral Feeding Tube | Neomed Co., Ltd. | 18 |
| TubeClear | Actuated Medical, Inc. | 14 |
| Corflo Ultra Lite NG | Corpak Medsystems | 13 |
| Aquarius | Degania Silicone, Ltd. | 11 |
| NeoMed Enteral Feeding Tube | Neomed Co., Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K100526 | 2010-04-22 |
Recalls Naming This Product
9 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 480 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 2850 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 710 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 2130 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 4710 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 70 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2020-01-17 | Class II | Under Investigation by firm | Feeding tube plastic tethered closure cap may possibly fracture or break. Possible health hazards: (1) Enteral feeding and medication administration could be possibly delayed, until replacement tube is placed into patient (2) Patient could | 170 | 2022-10-21 |
| Kentec Medical, LLC | 510(k) number | 2017-06-23 | Class II | Process control | Inadequate detectability of radiopaque stripes | 54 boxes of 10 individual units | 2020-04-14 |
| Kentec Medical, LLC | 510(k) number | 2017-06-23 | Class II | Process control | Inadequate detectability of radiopaque stripes | K100526 | 2020-04-14 |
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.