Identity
- Trade Name
- Urocare® Male Urinal to Latex Leg Bag Adapter FDA UDI
- Generic Name
- Open-ended wearable urine collection bag, non-sterile FDA UDI
- Device Name
- ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENT Replacement Male Urinal Adapter for all Urocare Male Urinal Systems: #94404, #94403, #94402, #94401, #94400, #94399 and Urinal Kits: #4404, #4403, #4402, #4401, #4400 and #4399. Includes Gasket-Ring #5999 preassembled. FDA UDI
- Model / Reference
- 6022 FDA UDI
- Description
- ADAPTER, MALE URINAL, LEG BAG, URINE COLLECTION, REUSABLE, REPLACEMENT Replacement Male Urinal Adapter for all Urocare Male Urinal Systems: #94404, #94403, #94402, #94401, #94400, #94399 and Urinal Kits: #4404, #4403, #4402, #4401, #4400 and #4399. Includes Gasket-Ring #5999 preassembled. FDA UDI
Identifiers
- Catalog Number
- 6022 FDA UDI
- Primary DI / UDI-DI
- 00792293060228 FDA UDI
- FDA Product Code
- NNX FDA UDINNW 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
- Outer Diameter — 0.84 Inch FDA UDIHeight — 1.24 Inch FDA UDIWeight — 0.013 Pound FDA UDI
Category: Open-ended wearable urine collection bag, non-sterilePenis/scrotum wearable urinal
Urocare® Male Urinal to Latex Leg Bag Adapter by Urocare Products, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Penis/scrotum wearable urinal.
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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 031ae4f0-151a-46f4-afa5-e672ce03f162 36 fields · synced Jun 8, 2026