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FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2)
FDA UDIClass I (US FDA UDI)
Identity
- Trade Name
- FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2) FDA UDI
- Generic Name
- Open-ended wearable urine collection bag, non-sterile FDA UDI
- Device Name
- 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 FDA UDI
- Model / Reference
- 6380 FDA UDI
- 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 FDA UDI
Identifiers
- Catalog Number
- 6380 FDA UDI
- Primary DI / UDI-DI
- 00792293063809 FDA UDI
- FDA Product Code
- FAQ FDA UDINNW FDA UDIKNX FDA UDI
- GMDN Term
- Open-ended wearable urine collection bag, non-sterile FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.10 Pound FDA UDI
Category: Open-ended wearable urine collection bag, non-sterile
FItz-All® Fabric Leg Bag Straps with Buttons (Set of 2) by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-ended wearable urine collection bag, non-sterile.
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- FItz-All® Fabric Leg Strap with Velcro® Fasteners, Small 13" ~ 20" DIA. — UROCARE PRODUCTS, INC. · Class II
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- Urocare® Leg Bag Holder, Lower Small — UROCARE PRODUCTS, INC. · Class II
- Urocare® Lower Fabric Leg Strap with Velcro® Fasteners, Small 7" ~ 13" DIA. — UROCARE PRODUCTS, INC. · Class I
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Urocare Products, Inc.
Sources (1)
- FDA UDI 0786f41d-a674-4005-a03b-d290792987cc 36 fields · synced May 31, 2026