Endo Carry-on Procedure Kit
Endo Carry-on Procedure Kit contains Revital-Ox Bedside Concentrate, Defendo Olympus 5-Piece Kit, Drawstring Pad, Cleanascope Advantage Liners, Extra Absorbant Pad, Lubricant, Gauze,…
Endo Carry-on Procedure Kit contains Revital-Ox Bedside Concentrate, Defendo Olympus 5-Piece Kit, Drawstring Pad, Cleanascope Advantage Liners, Extra Absorbant Pad, Lubricant, Gauze, DuoSwift Squeegee Cleaning Brush with Valve Brush, Suction Tubing, Gown, Syringe, Water and Detergent Label, Maxi Bite Block, Suction Canister Liner, and Solidifier.
2manufacturers in China registered for this device type
1,777catalogue 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 | 2024-10-31 |
| Record revised | 2025-11-14 (version 6) |
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 | Case of 10, box of 10, box of 12, box of 20, box of 14, box of 18 |
| Distribution end date | 2026-05-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 4009850 | In distribution | ||
| 4009767 | In distribution | ||
| 4010433 | In distribution | ||
| 4010806 | In distribution | ||
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| 100802 | In distribution | ||
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Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 10,257 |
| 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 |
| Essential Kit | Medivators Inc | 44 |
| 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
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 | Closed |
|---|---|---|---|---|---|---|---|
| Medivators Inc | UDI-DI | 2019-10-09 | Class II | Equipment maintenance | Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope le | 53,790 units total | 2020-12-11 |
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.