Intravesical Administration Kit
The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary…
The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into the urinary tract. The IVAK contains: one (1) Urinary Catheter, 16 Fr (Coude Olive Tip) with Luer lock, one (1) Urinary Catheter, 16 Fr (Straight Tip) with Luer lock, one (1) Luer lock Syringe, 5 mL, four (4) Luer lock Syringe, 20 mL, six (6) CSTD Syringe Adaptors, two (2) CSTD Catheter Luer lock Adaptors, one (1) Polybag
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 | Urogen Pharma Ltd., Israel |
|---|---|
| FDA product code | OHR |
| Device type | Catheter Care Tray |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 15 to 25 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IVAK | In distribution | |
| IVAK | In distribution | |
| IVAK | 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 |
| Duette™ | Poiesis Medical, LLC | 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 |
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.