Identity
- Trade Name
- Urocare® Leg Bag Holder, Upper Large FDA UDI
- Generic Name
- Open-ended wearable urine collection bag, non-sterile FDA UDI
- Device Name
- HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGE A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals. FDA UDI
- Model / Reference
- 6384 FDA UDI
- Description
- HOLDER, LEG BAG, LATEX-FREE, VELCRO, REUSABLE, UPPER LARGE A simple and cost effective solution to a prevent contact between the leg bag and the skin. Reducing sweating while allowing the skin to breathe freely. Their unique construction provides a simple method for securing a urine collection bag to the leg without the use of leg straps which are often the cause of circulation restriction in some individuals. FDA UDI
Identifiers
- Catalog Number
- 6384 FDA UDI
- Primary DI / UDI-DI
- 00792293063847 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 — 0.20 Pound FDA UDI
Category: Open-ended wearable urine collection bag, non-sterile
Urocare® Leg Bag Holder, Upper Large by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Open-ended wearable urine collection bag, non-sterile.
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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 98410a9b-ed88-421b-9344-5f4181b06f2d 36 fields · synced May 30, 2026