"Uro-Con® Teaxs-Style Male External Catheter, Medium 30mm 2"" Tube"

Primary DI
00792293102300
Brand
"Uro-Con® Teaxs-Style Male External Catheter, Medium 30mm 2"" Tube"
Company
UROCARE PRODUCTS, INC.
Model
510230
Catalog number
510230
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 purchasedContains:1 Uro-Con® Male External Catheter,Illustrated, application instructions on back of pouch/package"
Published
2018-05-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
10792293102307PackageGS150In Commercial Distribution
00792293102300PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1079229310230710792293102307
00792293102300007922931023007922931023000792293102300

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
Length2Inch
Outer Diameter30Millimeter
Weight0.012Pound

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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00792293063106"Urocare® Fabric Foley® Catheter/Tubing Strap Standard 18"""631063102018-05-30
00792293063113"Urocare® Fabric Foley® Catheter/Tubing Strap Arm 14"""631163112018-05-30
00792293063120"Urocare® Fabric Foley® Catheter/Tubing Strap Large 22"""631263122018-05-30
00792293063137"Urocare® Fabric Foley® Catheter/Tubing Strap Abdominal 34"""631363132018-05-30
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
00792293043993Urocare® Male Urinal Kit, Laced Closue, Small439943992018-04-11
00792293044006Urocare® Male Urinal Kit, Laced Closue, Medium440044002018-04-11
00792293044013Urocare® Male Urinal Kit, Laced Closue, Large440144012018-04-11
00792293044020Urocare® Male Urinal Kit, Velcro® Closue, Small440244022018-04-11
00792293044037Urocare® Male Urinal Kit, Velcro® Closue, Large440344032018-04-11
00792293044044Urocare® Male Urinal Kit, Laced Closue, Extra-Large440444042018-04-11
00792293044204"Urocare® Male Urinal Suspensory Garment, Laced Closure, Small 26"" to 38"" Waist"442044202018-04-12
00792293044211"Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38"" to 46"" Waist"442144212018-04-12
00792293062000Urocare® Latex-Free Anti-Snoring Strap620062002018-05-29
00792293944023Urocare® Male Urinal System, Velcro® Closue, Small94402944022018-04-11
00792293055002Uro-Prep® Protective Skin Barrier Wipes (Box of 50)550055002018-06-01

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