FDA UDI
In Commercial Distribution
🇺🇸 United States
Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist
DI: 00792293044211
·
Model: 4421
·
UROCARE PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Urocare® Male Urinal Suspensory Garment, Laced Closure, Large 38" to 46" Waist
- Primary DI
- 00792293044211
- Version / Model
- 4421
- Catalog Number
- 4421
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-12
- Public Version
- 2
- Public Version Date
- 2018-06-01
- Public Version Status
- Update
- Public Device Record Key
- 1f14ae98-ce57-453f-af25-444e4fb14893
Device Description
URINAL, MALE, SUSPENSORY GARMENT, URINE COLLECTION, COTTON, REUSABLE, LARGE 38" TO 46" (97CM TO 117CM) WAIST Replacement suspensory garment for Urocare Male Urinal systems & kits #94401 & #4401.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00792293044211 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.18 | Pound | |
| Device Size Text, specify | 38" to 46" Wasit | ||
| Device Size Text, specify | 97cm to 117cm Waist |