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Intravesical Administration Kit

FDA UDI

Class II (US FDA UDI)

by Urogen Pharma, Ltd.

Identity

Trade Name
Intravesical Administration Kit FDA UDI
Generic Name
Urological surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
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 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 FDA UDI
Model / Reference
IVAK FDA UDI
Description
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 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 FDA UDI

Identifiers

Catalog Number
300006 FDA UDI
Primary DI / UDI-DI
10854913006171 FDA UDI
FDA Product Code
OHR FDA UDI
GMDN Term
Urological surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.5130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Urological surgical procedure kit, non-medicated, single-use

Intravesical Administration Kit by Urogen Pharma, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urological surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Urogen Pharma, Ltd.

Sources (1)

  • FDA UDI 042da9b6-a8a7-41e2-baa0-5d84b48d08c0 36 fields · synced May 30, 2026