Bard® CritiCore® Collection Container
Catalogue number 153200, listed by C.R. Bard, Inc., United States, under Device, Urine Flow Rate Measuring, Non-Electrical, Disposable. 19 manufacturers in China are registered for this product code.
19manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Jinhua Kangdeli Medical Appliances Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| 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 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
Showing 12 of 19. All 19 manufacturers in China registered for Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | FFG |
| Device type | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-03-22 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 153200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health 200, LLC | 14 |
| Medline | Medline Industries, Inc. | 10 |
| Dover | Cardinal Health | 6 |
| AMSure® Urine Meter Drainage Bag | Amsino Medical Inc. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K811925 | 1981-09-08 |
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.