FDA UDI
In Commercial Distribution
🇺🇸 United States
Urocare® Male Urinal System, Laced Closue, Medium
DI: 00792293944009
·
Model: 94400
·
UROCARE PRODUCTS, INC.
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Urocare® Male Urinal System, Laced Closue, Medium
- Primary DI
- 00792293944009
- Version / Model
- 94400
- Catalog Number
- 94400
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-11
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 1624f364-018e-420b-8394-39384921b12f
Device Description
URINAL, MALE, URINE COLLECTION, KIT, REUSABLE, LACED CLOSURE, MEDIUM Contains: 1 Latex Leg Bag Large #9532, 1 Male Urinal Garment Laced Closure Small #4420, 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 2 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| NNX | Device, Incontinence, Urosheath Type, Non-Sterile | Gastroenterology, Urology | 876.5250 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45376 | 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. | No | Active |
| 58924 | Open-ended wearable urine collection bag, non-sterile | A non-sterile flexible plastic pouch designed to connect to a urinary catheter, a urinary condom catheter, or a urostomy bag, and to be strapped to the leg of a patient to collect discharged urine; it is designed with an opening for urine drainage. Also known as a leg bag, it is worn on the body to facilitate patient mobility. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00792293944009 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.04 | Pound | |
| Length | 9.00 | Inch | |
| Width | 6.25 | Inch | |
| Height | 4.00 | Inch | |
| Total Volume | 1000 | Milliliter | |
| Circumference | 40 | Millimeter | |
| Total Volume | 32 | Fluid Ounce | |
| Lumen/Inner Diameter | 20 | Millimeter |