Identity
- Trade Name
- MediChoice FDA UDI
- Generic Name
- Non-wearable adult urine collection bag, open-ended FDA UDI
- Device Name
- Bag Leg With Flip Valve 23 Inch Leg Strap, Button Hook Medium Capacity, Not Made With Natural Rubber Latex Vinyl 19 Oz (600ml) MediChoice FDA UDI
- Model / Reference
- SLB0019 FDA UDI
- Description
- Bag Leg With Flip Valve 23 Inch Leg Strap, Button Hook Medium Capacity, Not Made With Natural Rubber Latex Vinyl 19 Oz (600ml) MediChoice FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10885632102097 FDA UDI
- FDA Product Code
- FAQ FDA UDI
- GMDN Term
- Non-wearable adult urine collection bag, open-ended 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Category: Non-wearable adult urine collection bag, open-ended
MediChoice by Owens & Minor Distribution, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Non-wearable adult urine collection bag, open-ended.
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- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 18" — UROCARE PRODUCTS, INC. · Class I
- Urocare® Tubing White-Rubber with Connector and Clamp 0.31" x 18" — UROCARE PRODUCTS, INC. · Class II
- Conveen Standard — Coloplast A/S · Class I
- Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28" ID x 60" — UROCARE PRODUCTS, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Owens & Minor Distribution, Inc.
Sources (1)
- FDA UDI c330a41e-963a-49d2-b203-ee258a02f5ff 34 fields · synced May 29, 2026