FItz-All® Fabric Leg Strap with Velcro® Fasteners, Extra-Small 9" ~ 13" DIA. 6355

GUDID 10792293063554

STRAP, FABRIC, LEG BAG, LATEX-FREE, VELCRO FASTENERS, EXTRA-SMALL, 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

UROCARE PRODUCTS, INC.

Open-ended wearable urine collection bag, non-sterile

• Primary Device ID: 10792293063554
• NIH Device Record Key: 7a3c5c34-6ff0-45ed-bdd1-e38d87bad15a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FItz-All® Fabric Leg Strap with Velcro® Fasteners, Extra-Small 9" ~ 13" DIA.
• Version Model Number: 6355
• Catalog Number: 6355
• Company DUNS: 070637129
• Company Name: UROCARE PRODUCTS, INC.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM
• Phone: 909-621-6013
• Email: CUST.SUPPORT@UROCARE.COM

Device Dimensions

• Weight: 0.04 Pound
• Weight: 0.04 Pound
• Weight: 0.04 Pound
• Weight: 0.04 Pound
• Weight: 0.04 Pound
• Weight: 0.04 Pound

Device Identifiers

Device Issuing Agency	Device ID
GS1	00792293063557 [Primary]
GS1	10792293063554 [Package]; Contains: 00792293063557; Package: Case [12 Units]; In Commercial Distribution

FDA Product Code

• FAQ: Bag, Urine Collection, Leg, For External Use, Sterile

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-29

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