FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2)
Basic Information
- Brand Name
- FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2)
- Primary DI
- 00792293063809
- Version / Model
- 6380
- Catalog Number
- 6380
- 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
- 0786f41d-a674-4005-a03b-d290792987cc
Device Description
STRAP, LEG BAG, LATEX-FREE, VELCRO, BUTTONS, 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 straps. Large buttons can be easily grasped and slipped through the eyelets of most all vinyl disposable leg bags. The self-gripping fastener 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. Set Contains: 1 Upper leg strap #6374, 1 Lower leg strap #6375 and Illustrated Use and Care Instructions. * STRAPS NOT SOLD SEPARATELY ** BAGS MUST HAVE EYELETS FOR BUTTONS 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 | 10792293063806 | GS1 | Case | 12 | In Commercial Distribution | |
| Primary | 00792293063809 | 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 | Upper Strap: 2" (5cm) Wide, Fits up to 24" DIA. (61cm Ø), Lower Strap: 2" (5cm) Wide, Fits up to 18" DIA. (45cm Ø) | ||
| Weight | 0.10 | Pound |