| Primary Device ID | 00792293301352 |
| NIH Device Record Key | 5ee14eb1-f231-40b0-8513-1d6db869804f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm |
| Version Model Number | 530135 |
| Catalog Number | 530135 |
| Company DUNS | 070637129 |
| Company Name | UROCARE PRODUCTS, INC. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Outer Diameter | 35 Millimeter |
| Device Size Text, specify | 0 |
| Weight | 0.015 Pound |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Store in a cool, dry place away from direct sunlight |
| 00792293301246 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm | 2025-01-09 These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on th |
| 00792293301284 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm | 2025-01-09 These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on th |
| 00792293301314 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm | 2025-01-09 These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on th |
| 00792293301352 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm | 2025-01-09These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on the inside of the sheath which adheres to the skin when the catheter sheath is unrolled. Each Uro-Cath® II catheter has a thin, silicon 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. A retainer tray is provided to keep the catheters round shape while in storage. Uro-Cath® II catheters come in 24mm, 28mm, 31mm, 35mm and 40mm sizes 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–no “cookie-cutter” or “one fits all” instructions for all products like some similar products have. Once removed from the packaging and the retainer tray is removed, each catheter may be secured by simply unrolling the sheath over the shaft of the penis and firmly grasping around the shaft to ensure a secure fit for maximum comfort and security.
Contains:
1 Uro-Cath® II Male External Catheter,
Illustrated, application instructions on back of pouch/package. |
| 00792293301352 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm | 2025-01-09 These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on th |
| 00792293301406 - Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm | 2025-01-09 These male external catheters are commonly referred to as a “Self-Adhering” style because they are contain an adhesive on th |
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Uro-Safe® bags hav |
| 00792293781819 - Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | 2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP DRAIN VALVE, MEDIUM, 18 FL. OZ. (550 ML.)
Uro-Safe® bags ha |
| 00792293783202 - Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) | 2020-08-07 BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.)
Uro-Safe® bags ha |