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Urocare® Latex Reusable Urine Collection Bag, 10 oz. (300 mL.)
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Urocare® Latex Reusable Urine Collection Bag, 10 oz. (300 mL.) 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, SPORT-RIGHT SMALL, 10 FL. OZ. (300 ML.) Contains: 1 Standard Top Adapter #6002, 1 Latex Leg Bag with Odor Barrier, 1 Standard Bottom Drain Valve #6004, 3 Latex Leg Straps with buttons #6006 and Illustrated Use and Care Instructions. FDA UDI
- Model / Reference
- 9510 FDA UDI
- Description
- BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-RIGHT SMALL, 10 FL. OZ. (300 ML.) Contains: 1 Standard Top Adapter #6002, 1 Latex Leg Bag with Odor Barrier, 1 Standard Bottom Drain Valve #6004, 3 Latex Leg Straps with buttons #6006 and Illustrated Use and Care Instructions. FDA UDI
Identifiers
- Catalog Number
- 9510 FDA UDI
- Primary DI / UDI-DI
- 00792293095107 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
- Total Volume — 10 Fluid Ounce FDA UDITotal Volume — 300 Milliliter FDA UDIWeight — .028 Pound FDA UDIDepth — 1 Inch FDA UDIWidth — 10 Inch FDA UDIHeight — 4.75 Inch FDA UDI
Category: Open-ended wearable urine collection bag, non-sterile
Urocare® Latex Reusable Urine Collection Bag, 10 oz. (300 mL.) by Urocare Products, Inc. — Class II — FDA UDI — listed in FDA GUDID
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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 fa0471cf-eb78-4e57-b9e9-531c67ce3e05 36 fields · synced Jun 6, 2026