Essential Kit
Essential Kit includes Olympus DEFENDO Valves, Basin, Bedside Sponge, Transport Pad, Lube, Gauze, Cleaning Brush, Dirty Scope Label, and Suction Tubing
2manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yangzhou Fartley Medical Instrument Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 24 |
| Changzhou Endoclean Medical Device Co., Ltd. | Changzhou | Jiangsu | Repacker / relabeller | 13 |
Record
| Listed by | Medivators Inc, United States |
|---|---|
| FDA product code | NWU |
| Device type | Endoscope Introducer Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-01-21 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 18, box of 14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4000934 | In distribution | |
| 4000923 | In distribution | |
| 4000943 | In distribution | |
| 4000918 | In distribution | |
| 4000914 | In distribution | |
| 4000927 | In distribution | |
| 4000930 | In distribution | |
| 4000941 | In distribution | |
| 4001135 | In distribution | |
| 4000939 | In distribution | |
| 4000919 | In distribution | |
| 4001130 | In distribution | |
| 4000936 | In distribution | |
| 4001958 | In distribution | |
| 4000922 | In distribution | |
| 4001129 | In distribution | |
| 4000935 | In distribution | |
| 4000915 | In distribution | |
| 4000928 | In distribution | |
| 4000926 | In distribution | |
| 4000929 | In distribution | |
| 4000912 | In distribution | |
| 4001141 | In distribution | |
| 4001133 | In distribution | |
| 4001131 | In distribution | |
| 4000932 | In distribution | |
| 4000913 | In distribution | |
| 4000916 | In distribution | |
| 4000931 | In distribution | |
| 4000945 | In distribution | |
| 4000940 | In distribution | |
| 4000942 | In distribution | |
| 4001137 | In distribution | |
| 4000933 | In distribution | |
| 4000937 | In distribution | |
| 4000925 | In distribution | |
| 4002041 | In distribution | |
| 4000944 | In distribution | |
| 4000924 | In distribution | |
| 4000920 | In distribution | |
| 4000921 | In distribution | |
| 4000917 | In distribution | |
| 4000938 | In distribution | |
| 4001142 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10,257 |
| Endo Carry-on Procedure Kit | Medivators Inc | 1,777 |
| Custom Procedure KIT | Medivators Inc | 573 |
| VIA | Us Endoscopy | 519 |
| ACS | American Contract Systems, Inc. | 416 |
| Medline Industries, Inc. | Medline Industries, Inc. | 337 |
| Zutron Medical | Zutron Medical, L.L.C. | 80 |
| Medical Action Industries | Medical Action Industries, Inc. | 54 |
| Preclean Kit | Medivators Inc | 31 |
| VIA procedure kit – custom | Us Endoscopy | 29 |
| Endo Carry-on Custom Procedure Kit | Medivators Inc | 23 |
| Merit Medical® | Merit Medical Systems, Inc. | 17 |
Showing 12 of 23. All products under Endoscope Introducer Kit
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.