FItz-All® Fabric Leg Strap Kit With Velcro® Fasteners, Large (Set of 2)
STRAP KIT, 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…
STRAP KIT, 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. Set Contains: 1 Upper leg strap #6356, 1 Lower leg strap #6358 and Illustrated Use and Care Instructions. * BAGS MUST HAVE EYELETS FOR STRAP TIES TO PASS THROUGH
Who Else Makes It
Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter
Record
| Listed by | Urocare Products, Inc., United States |
|---|---|
| FDA product code | KNX |
| Device type | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-05-29 |
| Record revised | 2018-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 12 |
| Sizes | Weight 0.12 lb |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6370 | Weight 0.12 lb | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 71 |
| Urine Bag | Well Lead Medical Co., Ltd. | 64 |
| Dover | Cardinal Health 200, LLC | 53 |
| Medline | Medline Industries, Inc. | 19 |
| Rusch | Teleflex Medical LLC | 10 |
| Bard® Urine Meter with Bag | C.R. Bard, Inc. | 10 |
| Bard® Add-A-Foley Tray | C.R. Bard, Inc. | 10 |
| AMSure® Urinary Drainage Bag | Amsino Medical Inc. | 8 |
| Bard® Urinary Drainage Bag with Anti-Reflux Chamber | C.R. Bard, Inc. | 6 |
| Bard® Urinary Drainage Bag | C.R. Bard, Inc. | 6 |
| Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | Urocare Products, Inc. | 6 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K820565 | 1982-04-01 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.