AccessGUDID - DEVICE: Intravesical Administration Kit (10854913006171)

GUDID

Device Identifier (DI) Information

Brand Name: Intravesical Administration Kit
Version or Model: IVAK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 300006
Company Name: UROGEN PHARMA LTD

Primary DI Number: 10854913006171
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 534155213 *Terms of Use

Device 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60755	Urological surgical procedure kit, non-medicated, single-use	A collection of various urological surgical instruments and the necessary materials intended to be used during a urological surgical/endoscopic procedure; it is not a dedicated bladder irrigation set. The kit may be referred to as a procedure pack and is typically comprised of devices that individually are not dedicated to a specific type of urological surgical procedure, but are often supplied together to perform a specific type of urological procedure; it does not contain any pharmaceuticals. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OHR	Catheter Care Tray

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 042da9b6-a8a7-41e2-baa0-5d84b48d08c0
Public Version Date: June 24, 2025
Public Version Number: 1
DI Record Publish Date: June 16, 2025