Identity
- Trade Name
- Urine Bag FDA UDI
- Generic Name
- Wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Leg Bag 350ml Flocking FDA UDI
- Model / Reference
- F04D033530 FDA UDI
- Description
- Leg Bag 350ml Flocking FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936881174018 FDA UDI
- FDA Product Code
- KNX FDA UDI
- GMDN Term
- Wearable adult urine collection bag, open-ended 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Category: Wearable adult urine collection bag, open-ended
Urine Bag by Well Lead Medical Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wearable adult urine collection bag, open-ended.
- SteriGear — Sterigear, LLC · Class II
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Flexicare — FLEXICARE MEDICAL LIMITED · Class I
- Leg Bag — C. R. Bard, Inc. · Class I
- Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) — UROCARE PRODUCTS, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class I
- Dover — Cardinal Health 200, LLC · Class I
- AMSure® Urinary Leg Bag — AMSINO INTERNATIONAL, INC. · Class I
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
- Well Lead Medical Co., Ltd
Sources (1)
- FDA UDI c4e03b3e-923c-489a-aa2f-d07b5ad3548d 33 fields · synced Jun 8, 2026