Urocare® Male Urinal Kit, Velcro® Closue, Large
- Primary DI
- 00792293044037
- Brand
- Urocare® Male Urinal Kit, Velcro® Closue, Large
- Company
- UROCARE PRODUCTS, INC.
- Model
- 4403
- Catalog number
- 4403
- Device description
- URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, VELCRO CLOSURE, LARGE Contains: 1 Male Urinal Garment Velcro Closure Universal #4422, 1 Male Urinal Sheath Large #4410, 1 Male Urinal to Latex Leg Bag Adapter #6022, 1 Straight-Thru Adapter with Clamp #6005, 1 Bottom Drain Valve #6004 and Illustrated Use and Care Instructions.
- Published
- 2018-04-11
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- false
- Single use
- false
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 |
|---|
| 00792293044037 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00792293044037 | 00792293044037 | 792293044037 | 0792293044037 |
GMDN Terms
| Term | Definition |
|---|
| Penis/scrotum wearable urinal | A non-sterile urine drainage device designed for men with incontinence and a retracted penis that includes a front piece (a shaped cone) intended to contain both the penis and the scrotum to form a leak-proof seal around the male genitals. It is typically held in place with groin and waist straps and has a connected collection bag that functions as the reservoir for the collection of the urine. This device provides an alternative to inserting a catheter or wearing incontinence pads. This is a reusable device. |
Device Sizes
| Type | Value | Unit |
|---|
| Circumference | 40 | Millimeter |
| Depth | 1.63 | Inch |
| Height | 9.25 | Inch |
| Lumen/Inner Diameter | 20 | Millimeter |
| Total Volume | 9 | Fluid Ounce |
| Total Volume | 270 | Milliliter |
| Weight | 0.45 | Pound |
| Width | 5.63 | Inch |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store in a cool, dry place away from direct sunlight |
Regulatory Flags
- DUNS number
- 070637129
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- 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 |
| 00762123001660 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123001677 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123001684 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 00762123017876 | Conveen Security+ | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283304 | Freedom Clear Advantage | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283267 | Freedom Clear Advantage | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283342 | Freedom Clear Advantage | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283380 | Freedom Clear Advantage | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283410 | Freedom Clear Advantage | Coloplast A/S | NNX | 2022-12-06 |
| 05708932282246 | Freedom Clear | Coloplast A/S | NNX | 2022-12-06 |
| 05708932282017 | Freedom Clear | Coloplast A/S | NNX | 2022-12-06 |
| 05708932282215 | Freedom Clear | Coloplast A/S | NNX | 2022-12-06 |
| 05708932282116 | Freedom Clear | Coloplast A/S | NNX | 2022-12-06 |
| 05708932282260 | Freedom Clear | Coloplast A/S | NNX | 2022-12-06 |
| 05708932535939 | Conveen Optima | Coloplast A/S | NNX | 2022-12-06 |
| 05708932851299 | Conveen Optima | Coloplast A/S | NNX | 2022-12-06 |
| 05708932535953 | Conveen Optima | Coloplast A/S | NNX | 2022-12-06 |
| 05708932535984 | Conveen Optima | Coloplast A/S | NNX | 2022-12-06 |
| 00762123052433 | Conveen Optima | Coloplast A/S | NNX | 2022-12-06 |
| 05708932285292 | Freedom Active Cath | Coloplast A/S | NNX | 2022-12-06 |
| 05708932285124 | Freedom Active Cath | Coloplast A/S | NNX | 2022-12-06 |
| 05708932283489 | Freedom Active Cath | Coloplast A/S | NNX | 2022-12-06 |
| 05708932299503 | Freedom Active Cath | Coloplast A/S | NNX | 2022-12-06 |
| 05708932285186 | Freedom Cath | Coloplast A/S | NNX | 2022-12-06 |
| 05708932285063 | Freedom Cath | Coloplast A/S | NNX | 2022-12-06 |