FDA UDI
In Commercial Distribution
🇺🇸 United States
Urocare® Reusable Latex Leg Bag 44 oz.
DI: 00792293095442
·
Model: 9544
·
UROCARE PRODUCTS, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Urocare® Reusable Latex Leg Bag 44 oz.
- Primary DI
- 00792293095442
- Version / Model
- 9544
- Catalog Number
- 9544
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-02-05
- Public Version
- 9
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- b6d4a70f-68e5-4f7c-9fc3-3093ce71d843
Device Description
BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, EXTRA-LARGE, 44 FL. OZ. (1,300 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- No
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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 | 00792293095442 | GS1 |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 0.44 | Pound | |
| Depth | 1 | Inch | |
| Width | 4.75 | Inch | |
| Height | 20.625 | Inch | |
| Total Volume | 44 | Fluid Ounce | |
| Total Volume | 1300 | Milliliter |