FItz-All® Fabric Leg Strap with Velcro® Fasteners, Medium 17" ~ 23" DIA.
Basic Information
- Brand Name
- FItz-All® Fabric Leg Strap with Velcro® Fasteners, Medium 17" ~ 23" DIA.
- Primary DI
- 00792293063571
- Version / Model
- 6357
- Catalog Number
- 6357
- Company Name
- UROCARE PRODUCTS, INC.
- Labeler DUNS
- 070637129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-05-29
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 976e03ad-3c28-4271-8154-a8f4442fab72
Device Description
STRAP, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, LARGE, REUSABLE Fits most vinyl disposable urinary leg bags and offers a vast improvement in comfort over the standard latex leg straps packaged with most vinyl leg bags. A special elasticated-loop material distributes pressure evenly along the length of the strap reducing the risk of bruising, pressure sores, pulled hair, circulation restriction and burns caused by rubber/latex straps. Long strap ties can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fasteners can engage anywhere along the length of the strap making the strap fully adjustable to individual requirements. A special blend of elastic and cotton makes them durable and allows them to be hand or machine washed. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
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 |
|---|---|---|---|---|
| FAQ | Bag, Urine Collection, Leg, For External Use, Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| NNW | Bag, Urine Collection, Leg, For External Use, Non-Sterile | Gastroenterology, Urology | 876.5250 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | Gastroenterology, Urology | 876.5250 | 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 |
|---|---|---|---|---|---|---|
| Package | 10792293063578 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00792293063571 | GS1 |
Customer Contacts
- Phone
- 909-621-6013
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Can hold up to a 32 fl. oz. (1,000 mL.) leg bag | ||
| Device Size Text, specify | 2" (5cm) Wide, Fits: 17" ~ 23" DIA. (43cm x 58cm Ø) | ||
| Weight | 0.04 | Pound |