Identity
- Trade Name
- Urocare® Reusable Latex Leg Bag 32 oz. FDA UDI
- Generic Name
- Open-ended wearable urine collection bag, non-sterile FDA UDI
- Device Name
- BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE, 32 FL. OZ. (1,000 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions. FDA UDI
- Model / Reference
- 9532 FDA UDI
- Description
- BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, LARGE, 32 FL. OZ. (1,000 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions. FDA UDI
Identifiers
- Catalog Number
- 9532 FDA UDI
- Primary DI / UDI-DI
- 00792293095329 FDA UDI
- FDA Product Code
- KNX FDA UDINNW FDA UDI
- GMDN Term
- Open-ended wearable urine collection bag, non-sterile FDA UDI
Classification
- Device Class
- Class II 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
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 0.38 Pound FDA UDIDepth — 1 Inch FDA UDIWidth — 4.75 Inch FDA UDIHeight — 16.75 Inch FDA UDITotal Volume — 1000 Milliliter FDA UDITotal Volume — 32 Fluid Ounce FDA UDI
Category: Open-ended wearable urine collection bag, non-sterile
Urocare® Reusable Latex Leg Bag 32 oz. by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 II | Pending data |
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Manufacturer
- Manufacturer
- Urocare Products, Inc.
Sources (1)
- FDA UDI 2a8b219b-2c56-4105-8ceb-1255f38fe08b 36 fields · synced Jun 1, 2026