FDA.reportPublic FDA data

Intravesical Administration Kit

Primary DI
10854913006201
Brand
Intravesical Administration Kit
Company
UROGEN PHARMA LTD
Model
IVAK
Catalog number
300025
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 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
Published
2026-03-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHRCatheter Care Tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHRCatheter Care TrayGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10854913006201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1085491300620110854913006201

GMDN Terms#

Term, Definition table
TermDefinition
Urological surgical procedure kit, non-medicated, single-useA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-987-6436urogen.safety@fortrea.com

Regulatory Flags#

DUNS number
534155213
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10854913006188Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00112025-11-17
10854913006195Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé Olive TipUC00102025-11-17
20854913006185Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00112025-11-17
20854913006192Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé Olive TipUC00102025-11-17
10854913006157Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé TiemannTipUC00082025-11-16
10854913006164Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00092025-11-16
20854913006154Urinary Catheter, 16 FrUrinary Catheter, 16 Fr, Coudé TiemannTipUC00082025-11-16
20854913006161Urinary Catheter, 16 FrUrinary Catheter, 16 FrUC00092025-11-16
00854913006044Cystoject Syringe LeverCystojectSL00042021-01-04
10854913006171Intravesical Administration KitIVAK3000062025-06-16
10854913006096Ureteral Catheter Administration KitUCAK2000062020-05-17
10854913006119Urinary CatheterUrinary Catheter, 12 FrUC00052022-06-01
20854913006116Urinary CatheterUrinary Catheter, 12 FrUC00052022-06-01
10854913006126Urinary CatheterUrinary Catheter, 16 FrUC00062022-06-01
10854913006140Chilling Block 2 syringes + 3 vialsUCB00022022-02-03
10854913006089Chilling Block 2 syringes + 2 vials2019-03-13
20854913006048Cystoject Syringe LeverCystojectSL00042021-01-04
00854913006037Uroject12 Syringe LeverUroject12SL00022019-02-11
108549130060587 Fr. Ureteral catheter Ureteral catheter2019-02-11
10854913006072Chilling Block 2 syringes + 3 vials2019-03-13

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Primary DI, Brand, Company table
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10198956214569CARDINAL HEALTHCardinal Health 200, LLCOHR2025-11-28
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10197106910979CARDINAL HEALTHCardinal Health 200, LLCOHR2025-04-23
10197344148981MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-07
10197344148998MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197344149001MEDLINEMEDLINE INDUSTRIES, INC.OHR2025-04-02
10197106963685CARDINAL HEALTHCardinal Health 200, LLCOHR2025-03-14
10198459028793Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-07-29
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10198459044588Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2024-06-23
10195327610999MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-25
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10193489939262MedlineMEDLINE INDUSTRIES, INC.OHR2024-03-05
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10653160995791Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-12-21
10850053289191SURGYCOSurgyco LLCOHR2023-12-15
10195327443023Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10195327443108Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-15
10197106420386CARDINAL HEALTHCardinal Health 200, LLCOHR2023-10-12
10195327512514Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-10-01
10195327503192Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-09-17
10610075177063ApogeeHOLLISTER INCORPORATEDOHR2023-08-22
10195327476946Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-08-13
10195327245474Medline Industries, Inc.MEDLINE INDUSTRIES, INC.OHR2023-07-29
10653160995517Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-07-29
10195327195236MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10195327242862MedlineMEDLINE INDUSTRIES, INC.OHR2023-06-08
10653160995067Centurion Medical Products CorpMEDLINE INDUSTRIES, INC.OHR2023-04-30