FDA UDI
In Commercial Distribution
🇺🇸 United States
Uro-Kit® Reusable Latex Leg Bag System 10 oz.
DI: 00792293995100
·
Model: 99510
·
UROCARE PRODUCTS, INC.
Product Codes
5
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Uro-Kit® Reusable Latex Leg Bag System 10 oz.
- Primary DI
- 00792293995100
- Version / Model
- 99510
- Catalog Number
- 99510
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-04-10
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 562dbe8b-5920-4ee7-a275-5bbfb4103551
Device Description
BAG, URINE COLLECTION, LEG, KIT, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT SMALL 10 FL. OZ. (300 ML.) Contains: 1 Reusable Latex Urinary Leg Bag #9510, 1 Fabric Sport Bag Strap #6342, 1 Bottle of Urolux Appliance Cleanser #700204, 1 Small Parts Cleansing Brush #7003, 1 Adaptor with Thumb Clamp #6005, 1 Tubing 18" Long with Connector #6016, 14 Male External Catheters #5122535 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 |
| EXJ | Device, Incontinence, Urosheath Type, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| FFA | Tube, Drainage, Suprapubic | Gastroenterology, Urology | 876.5090 | 2 |
| MDZ | Cleaners, Medical Devices | General Hospital | 880.6992 | 2 |
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 | 00792293995100 | GS1 |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1.72 | Pound | |
| Width | 6.0 | Inch | |
| Height | 6.75 | Inch | |
| Depth | 10.0 | Inch | |
| Total Volume | 300 | Milliliter | |
| Total Volume | 10 | Fluid Ounce |