Merit Medical®
17 catalogue numbers from 00884450310519, listed by Merit Medical Systems, Inc., United States, under Endoscope Introducer Kit. 2 manufacturers in China are registered for this product code.
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 | Merit Medical Systems, 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 | 2019-03-21 |
| Record revised | 2025-05-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00884450310519 | In distribution | |
| 00884450311998 | In distribution | |
| 00884450535721 | In distribution | |
| 00884450307267 | In distribution | |
| 00884450363102 | In distribution | |
| 00884450320846 | In distribution | |
| 00884450267431 | In distribution | |
| 00884450551974 | In distribution | |
| 00884450279182 | In distribution | |
| 00884450409589 | In distribution | |
| 00884450413258 | In distribution | |
| 00884450409442 | In distribution | |
| 00884450360408 | In distribution | |
| 00884450396704 | In distribution | |
| 00884450312001 | In distribution | |
| 00884450310304 | In distribution | |
| 00884450282212 | 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 |
| 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 |
Showing 12 of 23. All products under Endoscope Introducer Kit
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. 1 is recorded with the root cause “No Marketing Application”: the device was distributed without the premarket submission its class requires, a compliance finding rather than a defect. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2024-06-11 | Class II | No Marketing Application | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health. | 2388 kits |
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.