Uro-Con® Texas-Style Male External Catheter, Large 35mm 2" Tube with Urofoam®-1

Primary DI
10792293112351
Brand
Uro-Con® Texas-Style Male External Catheter, Large 35mm 2" Tube with Urofoam®-1
Company
UROCARE PRODUCTS, INC.
Model
511235
Catalog number
511235
Device description
These male external catheters are commonly referred to as a “Texas-Style” because they employ a three-piece construction technique. Each Uro-Con® catheter has a thin, latex sheath similar to a condom—which is rolled over the head and shaft of the penis—and is attached to a 4"(10cm) or 2"(5cm) white-rubber tube—where urine is drained from into a bag or other collection device—by an plastic catheter insert. Using a “Condom” type sheath makes these catheters “fully collapsible” to prevent pooled urine a major cause of skin irritation and break-down. Uro-Con® catheters range in size from 25mm, our smallest, to 35mm, our largest in 5mm increments to suit a variety of individual requirements. They are packaged individually in a window pouch allowing for quick, easy product identification without opening the pouch. The back side of the pouch contains detailed, illustrated, application instructions relative to the product purchased Contains: 1 Uro-Con® Male External Catheter, 1 Urofoam®-1 Single-Sided Adhesive Foam Strip, Illustrated, application instructions on back of pouch/package
Published
2018-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10792293112351PackageGS150In Commercial Distribution
00792293112354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079229311235110792293112351
00792293112354007922931123547922931123540792293112354

GMDN Terms#

Term, Definition table
TermDefinition
Urinary incontinence penis sheath/port, single-use, non-sterileA non-sterile device intended to be worn on or over the penis by an incontinent patient to channel urine from the penis, via a tube, into a collection bag. It consists of a penis-worn sheath (e.g., condom-catheter) or adhesive port (e.g., glans penis attachment), and may include a portion of tubing; the bag is not included. This device provides an alternative to inserting a catheter through the urethra, especially when difficulty is encountered in insertion or retention. It may be used to treat urinary incontinence or for non-ambulatory patients. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length2Inch
Outer Diameter35Millimeter
Weight0.015Pound

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
909-621-6013CUST.SUPPORT@UROCARE.COM

Regulatory Flags#

DUNS number
070637129
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm5301245301242025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm5301285301282025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm5301315301312025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm5301355301352025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm5301405301402025-01-01
00792293781802Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78180781802020-07-30
00792293781819Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)78181781812020-07-30
00792293783202Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78320783202020-07-30
00792293783219Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)78321783212020-07-30
00792293791801Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79180791802020-07-30
00792293791818Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.)79181791812020-07-30
00792293793201Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79320793202020-07-30
00792293793218Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.)79321793212020-07-30
10792293042009Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.)420042002018-04-10
10792293060096Urocare® Tubing Connector, Small 0.31" OD x 2.25"600960092018-06-01
10792293060102Urocare® Tubing Connector, Large 0.38" OD x 2.25"601060102018-06-01
10792293060133Urocare® Catheter Connector, Small 0.31" OD x 3"601360132018-05-31
10792293060140Urocare® Catheter Connector, Large 0.38" OD x 3"601460142018-05-31
10792293060164Urocare® Tubing White-Rubber with Connector 0.31" ID x 18"601660162018-05-31
10792293060171Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18"601760172018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00792293301246Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301284Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301314Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301352Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mmUROCARE PRODUCTS, INC.NNX2025-01-01
00792293301406Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mmUROCARE PRODUCTS, INC.NNX2025-01-01
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