FDA.reportPublic FDA data

Urinary Catheter

Primary DI
10854913006126
Brand
Urinary Catheter
Company
UROGEN PHARMA LTD
Model
Urinary Catheter, 16 Fr
Catalog number
UC0006
Device description
The Urinary Catheter is a single use 16 Fr urethral catheter with a fixed female Luer lock hub. The catheter has a Coudé (Tiemann) tip, is 40 cm long and made of biocompatible soft PVC and is uncoated.
Published
2022-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EZCCatheter, Coude
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EZCCatheter, CoudeGastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211032000Urinary Catheter 12 Fr, Urinary Catheter 16 FrUrogen Pharma, Ltd.2021-11-19KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20854913006123PackageGS110In Commercial Distribution
10854913006126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2085491300612320854913006123
1085491300612610854913006126

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral drainage catheterA sterile, flexible tube intended to be inserted one-time through the urethra to the urinary bladder, by the patient/user or a healthcare provider, to provide urine drainage, typically for an individual who is physiologically incapable of voiding. It is typically made of polyvinyl chloride (PVC), and may be coated with a lubricating substance (e.g., acquires a smooth and mucous surface when brought in contact with water). The distal end can have various tip designs [e.g., open-ended, rounded with a side hole(s)], and the proximal end typically connects to a urine collection container. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge16French
Catheter Length40Centimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
534155213
Device count
1
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
10854913006201Intravesical Administration Kit IVAK3000252026-03-15
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
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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