Uro-Cath® Molded-Latex Male External Catheter, Large 35mm

Primary DI
00792293201355
Brand
Uro-Cath® Molded-Latex Male External Catheter, Large 35mm
Company
UROCARE PRODUCTS, INC.
Model
520135
Catalog number
520135
Device description
These male external catheters are commonly referred to as a “Molded-Latex” style because they are dipped from a single piece of latex without seams rather than assembled from multiple components. Each Uro-Cath® catheter has a thin, latex sheath section similar to a condom at one end—the part that is rolled over the head and shaft of the penis—and a heavier funnel-shaped, cup section at the other—where urine is drained from into a bag or other collection device—making them virtually “twist-proof” by their unique design. Uro-Cath® catheters range in size from 25mm, our smallest, to 40mm, 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-Cath® Male External Catheter, 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

Related Records

Contact Domains

Product Codes

CodeName
NNXDevice, Incontinence, Urosheath Type, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NNXDevice, Incontinence, Urosheath Type, Non-SterileGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10792293201352PackageGS150In Commercial Distribution
00792293201355PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1079229320135210792293201352
00792293201355007922932013557922932013550792293201355

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Outer Diameter35Millimeter
Weight0.014Pound

Sterilization Methods

Method

Contacts

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

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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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