Prelude Snap 165™
Catalogue number 10884450484491, listed by Merit Medical Systems, Inc., United States, under Accessories, Catheter. 33 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 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 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter
Record
| Listed by | Merit Medical Systems, Inc., United States |
|---|---|
| FDA product code | KGZ |
| Device type | Accessories, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-12-03 |
| Record revised | 2024-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 10884450484491 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedDrain | Armm, Inc. | 77 |
| Silicone Drainage Tube | Fortune Medical Instrument Corp. | 74 |
| Typenex Wound Drainage | Typenex Medical, LLC | 56 |
| Cook | Cook Incorporated | 49 |
| Marina Medical | Marina Medical Instruments, Inc. | 48 |
| Curaplex | Bound Tree Medical, LLC | 36 |
| Mediplus | Mediplus Ltd. | 29 |
| AlliedSil™ Silicone Tubing | Implantech Associates, Inc. | 24 |
| Arrow | Teleflex Medical LLC | 23 |
| Silicone Thoracic Catheters | Atrium Medical Corporation | 21 |
| Neff | Cook Incorporated | 18 |
| Silhouette | Cook Incorporated | 16 |
Showing 12 of 111. All products under Accessories, Catheter
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2009-09-29 | Not classified | Other | Potential sterility breach caused by excessive shipment damage. | 5 fixation devices | 2009-12-15 |
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.