Mediplus
Cystometry 8fr & rectal catheter with introducer set
33manufacturers in China registered for this device type
29catalogue numbers in this listing
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 | Mediplus Ltd., United Kingdom |
|---|---|
| FDA product code | KGZ |
| Device type | Accessories, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-16 |
| Record revised | 2024-08-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10, pack of 25 |
| Sizes | Catheter gauge 4.5 to 21 Fr; length 20 to 200 cm |
| Distribution end date | 2024-08-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5736 | Length 30.0 cm | In distribution |
| 5206 | Catheter Gauge 6.0 Fr | In distribution |
| 5100N | Catheter Gauge 4.5 Fr | In distribution |
| 5415 | Length 200.0 cm | In distribution |
| 5400 | Length 200.0 cm | In distribution |
| 5100 | Catheter Gauge 4.5 Fr | In distribution |
| 5415i | Catheter Gauge 4.5 Fr | In distribution |
| 5424 | Length 38.5 cm | In distribution |
| 5435 | Length 200.0 cm | In distribution |
| 5106 | Catheter Gauge 6.0 Fr | In distribution |
| 5208 | Catheter Gauge 8.0 Fr | In distribution |
| 5405 | Catheter Gauge 4.5 Fr | In distribution |
| 5200 | Catheter Gauge 10.0 Fr | In distribution |
| 5457 | Length 38.5 cm | In distribution |
| 5703 | Catheter Gauge 8.0 Fr | In distribution |
| 5145 | Length 200.0 cm | In distribution |
| 5712 | Catheter Gauge 10.0 Fr | In distribution |
| 5108 | Catheter Gauge 8.0 Fr | In distribution |
| 5212 | Catheter Gauge 12.0 Fr | In distribution |
| 5702 | Length 65.0 cm | In distribution |
| 5410 | Length 200.0 cm | In distribution |
| 5732 | Catheter Gauge 8.0 Fr | In distribution |
| 5717 | Length 20.0 cm | In distribution |
| 5716 | Length 65.0 cm | In distribution |
| 5105 | Catheter Gauge 8.0 Fr | Withdrawn |
| 5104 | Catheter Gauge 6.0 Fr | Withdrawn |
| 5200S | Catheter Gauge 10.0 Fr | Withdrawn |
| 5450 | Length 35.0 cm | Withdrawn |
| 5610 | Withdrawn |
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 |
| 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 |
| Argyle | Cardinal Health | 16 |
Showing 12 of 111. All products under Accessories, Catheter
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.