Davol® Pediatric Cath Kit
Catalogue number 0035640, listed by C.R. Bard, Inc., United States, under Collector, Urine, Pediatric, For Indwelling Catheter. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Zhejiang (4), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Shanghai Medicines & Health Products IMP. & EXP. Co., Ltd. | Shanghai | Shanghai | Exporter | 25 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Changzhou CareU Medical Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 9 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | FFH |
| Device type | Collector, Urine, Pediatric, For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-06 |
| Record revised | 2023-07-31 (version 3) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50 |
| Sizes | Catheter gauge 8 Fr; length 2.7 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0035640 | Catheter Gauge 8 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endure Industries | Endure Industries, Inc. | 2 |
| Davol® Female Cath Kit | C.R. Bard, Inc. | 2 |
| Davol® Infant Cath Kit | C.R. Bard, Inc. | 1 |
| Cook | Cook Incorporated | 1 |
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.