Duette™
16FR Duette™ Indwelling TempSensing Urinary Catheter Urine Meter Tray
12manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (1). 7 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 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
Record
| Listed by | Poiesis Medical, LLC, United States |
|---|---|
| FDA product code | OHR |
| Device type | Catheter Care Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Premarket notification | Exempt |
| Record published | 2017-08-11 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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, manufacturing date |
| Storage | Special storage condition: Keep Out of Sunlight; Storage environment temperature 10 to 50 °C |
| Sizes | Catheter gauge 14 to 18 Fr |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| K-10016UT | Catheter Gauge 16 Fr | 10 | In distribution |
| K-10016U | Catheter Gauge 16 Fr | 10 | In distribution |
| K-10014U | Catheter Gauge 14 Fr | 10 | In distribution |
| K-10018 | Catheter Gauge 18 Fr | 10 | In distribution |
| K-10016 | Catheter Gauge 16 Fr | 10 | In distribution |
| K-10018U | Catheter Gauge 18 Fr | 10 | In distribution |
| K-10014 | Catheter Gauge 14 Fr | 10 | In distribution |
| K-10018UT | Catheter Gauge 18 Fr | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline | Medline Industries, Inc. | 267 |
| Medline Industries, Inc. | Medline Industries, Inc. | 75 |
| TruAdvance™ | HR Pharmaceuticals Inc. | 29 |
| Cardinal Health | Cardinal Health 200, LLC | 16 |
| VaPro Plus Pocket Kit | Hollister Incorporated | 10 |
| LSL Healthcare | Lsl Industries, Inc. | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 6 |
| Medical Action Industries | Medical Action Industries, Inc. | 5 |
| TruCath | HR Pharmaceuticals Inc. | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 5 |
| Closed System Foley Catheter Tray, Pre-Connected Closed Circuit: 12 Fr | Dynarex Corp. | 4 |
| Bardia® Foley Catheter Insertion Tray | C.R. Bard, Inc. | 4 |
Showing 12 of 42. All products under Catheter Care Tray
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.