Uro-Cath® Molded-Latex Male External Catheter, Extra-Large 40mm
- Primary DI
- 10792293201406
- Brand
- Uro-Cath® Molded-Latex Male External Catheter, Extra-Large 40mm
- Company
- UROCARE PRODUCTS, INC.
- Model
- 520140
- Catalog number
- 520140
- 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
Product Codes
| Code | Name |
|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10792293201406 | Package | GS1 | 50 | In Commercial Distribution |
| 00792293201409 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 10792293201406 | 10792293201406 | | |
| 00792293201409 | 00792293201409 | 792293201409 | 0792293201409 |
GMDN Terms
| Term | Definition |
|---|
| Urinary incontinence penis sheath/port, single-use, non-sterile | A 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 |
|---|
| Device Size Text, specify | 0 | |
| Outer Diameter | 40 | Millimeter |
| Weight | 0.015 | Pound |
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 | Catalog | Published |
|---|
| 00792293301246 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm | 530124 | 530124 | 2025-01-01 |
| 00792293301284 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm | 530128 | 530128 | 2025-01-01 |
| 00792293301314 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm | 530131 | 530131 | 2025-01-01 |
| 00792293301352 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm | 530135 | 530135 | 2025-01-01 |
| 00792293301406 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm | 530140 | 530140 | 2025-01-01 |
| 00792293781802 | Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | 78180 | 78180 | 2020-07-30 |
| 00792293781819 | Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | 78181 | 78181 | 2020-07-30 |
| 00792293783202 | Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) | 78320 | 78320 | 2020-07-30 |
| 00792293783219 | Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) | 78321 | 78321 | 2020-07-30 |
| 00792293791801 | Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | 79180 | 79180 | 2020-07-30 |
| 00792293791818 | Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | 79181 | 79181 | 2020-07-30 |
| 00792293793201 | Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) | 79320 | 79320 | 2020-07-30 |
| 00792293793218 | Uro-Safe® Disposable Vinyl Leg Bag 32 oz. (1,000 mL.) | 79321 | 79321 | 2020-07-30 |
| 10792293042009 | Urocare® Disposable Urinary Drainage Bag 64 oz. (2,000 mL.) | 4200 | 4200 | 2018-04-10 |
| 10792293060096 | Urocare® Tubing Connector, Small 0.31" OD x 2.25" | 6009 | 6009 | 2018-06-01 |
| 10792293060102 | Urocare® Tubing Connector, Large 0.38" OD x 2.25" | 6010 | 6010 | 2018-06-01 |
| 10792293060133 | Urocare® Catheter Connector, Small 0.31" OD x 3" | 6013 | 6013 | 2018-05-31 |
| 10792293060140 | Urocare® Catheter Connector, Large 0.38" OD x 3" | 6014 | 6014 | 2018-05-31 |
| 10792293060164 | Urocare® Tubing White-Rubber with Connector 0.31" ID x 18" | 6016 | 6016 | 2018-05-31 |
| 10792293060171 | Urocare® Tubing White-Rubber with Connector & Sterile 0.31" x 18" | 6017 | 6017 | 2018-05-31 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00792293301246 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Small 24mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301284 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Small 28mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301314 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Medium/Large 31mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301352 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, Large 35mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
| 00792293301406 | Uro-Cath® II Silicone Self-Adhering Male External Catheter, X-Large 40mm | UROCARE PRODUCTS, INC. | NNX | 2025-01-01 |
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