| Primary Device ID | 10854913006171 |
| NIH Device Record Key | 042da9b6-a8a7-41e2-baa0-5d84b48d08c0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Intravesical Administration Kit |
| Version Model Number | IVAK |
| Catalog Number | 300006 |
| Company DUNS | 534155213 |
| Company Name | UROGEN PHARMA LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 25 Degrees Celsius |
| 10854913006171 - Intravesical Administration Kit | 2025-06-24The 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 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 |
| 10854913006171 - Intravesical Administration Kit | 2025-06-24 The Intravesical Administration Kit (IVAK) is designed for the convenience of the user for administration of gels or fluids into |
| 20854913006116 - Urinary Catheter | 2022-06-09 The Urinary Catheter is a single use 12 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiema |
| 10854913006126 - Urinary Catheter | 2022-06-09 The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiema |
| 10854913006140 - Chilling Block | 2022-02-11 |
| 20854913006048 - Cystoject Syringe Lever | 2021-01-12 The Cystoject Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 30 mL syr |
| 10854913006096 - Ureteral Catheter Administration Kit | 2020-05-25 The Ureteral Catheter Administration Kit is designed for the convenience of the user for administration of gels or fluids into t |
| 00854913006037 - Uroject12 Syringe Lever | 2020-05-01 The Uroject12 Syringe Lever is a reusable device that is intended to assist in the delivery of fluids from a standard 20 mL syr |
| 10854913006058 - 7 Fr. Ureteral catheter | 2020-04-22 |