FDA.reportPublic FDA data

United Urologics Closed System Catheter

Primary DI
00818016020123
Brand
United Urologics Closed System Catheter
Company
UNITED UROLOGICS INC
Model
UU14S
Published
2017-03-29
Public version status
Update
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
KODCatheter, Urological

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818016020120PackageGS1100In Commercial Distribution
00818016020123PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081801602012010818016020120
00818016020123008180160201238180160201230818016020123

GMDN Terms#

Term, Definition table
TermDefinition
Single-administration urethral catheterization kit, single-useA sterile collection of devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for one-time, self-urinary catheterization. The catheter is inserted through the urethra by the patient to provide urine drainage. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080428707
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00818016020314United Urologics Insertion KitUUIK012017-03-22
00818016020635United Urologics Closed System CatheterUU16R2017-03-22
00818016020109United Urologics Closed System CatheterUU16R2019-06-17
10818016020311United Urologics Insertion KitUUIK012017-03-22
00818016020017United Urologics Closed System Catheter KitUU062017-03-22
00818016020024United Urologics Closed System CatheterUU082017-03-22
00818016020031United Urologics Closed System CatheterUU102017-03-22
00818016020048United Urologics Closed System CatheterUU122017-03-22
00818016020055United Urologics Closed System CatheterUU142017-03-22
00818016020062United Urologics Closed System CatheterUU162017-03-22
00818016020079United Urologics Closed System CatheterUU182017-03-22
00818016020086United Urologics Closed System CatheterUU12R2017-03-22
00818016020093United Urologics Closed System CatheterUU14R2017-03-22
00818016020103United Urologics Closed System CatheterUU16R2017-03-22
00818016020116United Urologics Closed System CatheterUU12S2017-03-22
00818016020130United Urologics Closed System CatheterUU12C2017-03-22
00818016020147United Urologics Closed System CatheterUU14C2017-03-22
00818016020154United Urologics Closed System CatheterUU16C2017-03-22
00818016020161United Urologics Closed System Catheter KitUU06K2017-03-22
00818016020178United Urologics Closed System Catheter KitUU08K2017-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
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10192253066265DoverCardinal Health 200, LLCKOD2024-09-04